search
Back to results

A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL) (DEEPER REVEAL)

Primary Purpose

Peripheral Arterial Disease, Critical Limb Ischemia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bare Temporary Spur Stent System
Sponsored by
ReFlow Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease, Critical Limb Ischemia, Infrapopliteal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Pre-Procedure Inclusion Criteria:

  1. Subject willing and able to provide informed consent and able to comply with the study protocol and follow up. Subjects who are unable to sign due to a physical limitation may have a witness, including a family member, sign on their behalf.
  2. Life expectancy greater than 1 year in the investigator's opinion.
  3. Male or non-pregnant female ≥18 years of age at time of consent.
  4. Subjects must have chronic (greater than 14 days) symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 4-5, rest pain (R 4), and/or minor tissue loss (R5), that in the opinion of the investigator are not amenable to conservative medical therapy and require endovascular intervention for alleviation of symptoms and tissue preservation.
  5. For subjects with bilateral disease, planned treatment of the contralateral limb must either be performed greater than or equal to 3 days prior to the index procedure or greater than or equal to 7 days following the index procedure.

Angiographic Inclusion Criteria:

  1. Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels, with target lesion that can be successfully crossed via the true lumen with a guidewire (no subintimal crossing).
  2. Iliac, SFA and popliteal inflow lesions can be treated using standard of care during the index procedure or greater than or equal to 3 days prior.

    Note:

    1. Inflow lesions treated intraprocedure must be treated first, prior to consideration of treatment of infrapopliteal lesions.
    2. Treatment of in-stent restenosis in inflow treatment is permitted, provided that stents are not fractured or otherwise compromised.
    3. Distal embolic protection is strongly encouraged in cases where atherectomy is used.
    4. Inflow lesions must have a healthy vessel segment of greater than 30 mm between the study lesion and the treated segment, defined as less than 50% stenosis without aneurysmal segments.
    5. Inflow treatment must be successful, prior to treatment of the target lesion, resulting in stenosis less than or equal to 30%, without resulting flow limiting dissection, thrombus, or aneurysm by angiography.
  3. Target vessel(s) reconstitute(s) at or above the ankle, with the target treated segment ending at least 10 mm above the ankle joint.

    Note:

    1. If the anterior tibial or posterior tibial arteries are treated, there must be inline flow to the foot.
    2. If the peroneal artery is treated, there must be at least one collateral supplying the foot.
    3. In all cases, patent runoff (no lesions with greater than 50% stenosis) must be present via the dorsalis pedis and/or plantar arteries
  4. Target lesion must be located in the tibial arteries. If vessel sizing remains appropriate, treatment may extend into the distal popliteal (P3) segment.
  5. Target vessel reference diameter is measured to be between 2.5 to 4.5 mm in diameter assessed by one of the following methods after successful completion of guidewire crossing of the lesion site:

    1. Intravascular Ultrasound (IVUS) (primary)
    2. Visual estimate using Angiography (secondary)
  6. Target lesion length is less than or equal to 210mm in length. Tandem lesions that are less than or equal to 4 cm should be treated as one lesion. Multiple discrete lesions may be treated provided cumulative length is less than or equal to 210 mm.
  7. Successful pre-dilatation of the target lesion defined as resulting in stenosis less than or equal to 50% and/or inner lumen diameter greater than or equal to 2.0 mm in diameter, without resulting flow limiting dissection, thrombus, or aneurysm by angiography prior to the insertion of the Bare Temporary Spur Stent System.
  8. Only one limb and one contiguous vessel may be enrolled per subject. If required, a second modality may be used for treatment in the non-target infrapopliteal vessel.

    Note:

    1. Distal embolic protection is strongly recommended in cases using atherectomy.
    2. Treatment of the target vessel/lesion may be performed only if treatment of the non-target lesion is successful without resulting flow limiting (Type D or greater) dissection, thrombus, or aneurysm by angiography.
    3. Treatment of non-target lesions must be parallel to, and not contiguous with, the target lesion.
  9. If pre-screening with duplex ultrasound, angiography, CTA, or MRA has been performed less than or equal to 365 days prior to the procedure, intra-procedure angiography of the aorto-iliac vasculature is not required, however, the femoropopliteal inflow must still be imaged using angiography during the index procedure.
  10. Retrograde access (in the infrapopliteal arteries) is permitted for lesion crossing; however, the Bare Temporary Spur Stent System must be deployed from antegrade (above the knee, either ipsilateral or contralateral) access.

Pre-procedure Exclusion Criteria:

  1. Subject unwilling or unlikely to comply with the 1-year duration of the study in the opinion of the investigator.
  2. Subject is pregnant or planning to become pregnant during the course of the trial.
  3. Subject has an active systemic infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
  4. Subject has osteomyelitis proximal to the phalanges. Osteomyelitis in the digit(s) of the target foot is permitted.
  5. Wounds must be confined to the foot below the ankle. Heel wounds are excluded.
  6. Planned major (above the ankle) amputation of the target limb. A planned or previous minor (trans metatarsal amputation or digit amputation) is permitted.
  7. Recent myocardial infarction or stroke less than 90 days prior to the index procedure.
  8. Symptomatic acute heart failure NYHA class III or greater.
  9. Impaired renal function (eGFR less than or equal to 25 mL/min) within 30 days of procedure or end stage renal disease on dialysis.
  10. Inability to tolerate dual antiplatelet and/or anticoagulation therapy.
  11. Known allergies or sensitivities to heparin, antiplatelet drugs, other anticoagulant therapies which could not be substituted, or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
  12. The subject is currently enrolled in another investigational device or drug trial that interferes with the study endpoints.
  13. Known allergy to nitinol or nickel.
  14. Bypass surgery of the target vessel(s). Prior bypass above the level of the infrapopliteal arteries is permitted.

Angiographic Exclusion Criteria

  1. Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion. Inflow must also be free of aneurysmal segments.
  2. Fractured or otherwise compromised stents in the target vessel or inflow vessel.
  3. In-stent restenosis in the target vessel.
  4. Previous treatment of inflow lesions performed less than or equal to 7 days prior to the index procedure.
  5. Previous treatment of the target vessel less than or equal to 90 days prior to index procedure.
  6. Angiographic evidence of thrombus within target limb.
  7. Extremely severe calcification that, in the investigator's opinion, would not be amenable to PTA.
  8. Type D dissections or greater incurred during CTO crossing (see Appendix I for definitions).
  9. Significant (greater than or equal to 50%) stenosis of inflow arteries or unsuccessful treatment of inflow lesions.
  10. Distance from access to lesion is too long for a 135 cm working length of the Bare Temporary Spur Stent System catheter.

Sites / Locations

  • St. Bernards Heart and VascularRecruiting
  • Arkansas Heart HospitalRecruiting
  • Vascular & Interventional Specialist of Orange CountyRecruiting
  • Vascular Care Connecticut (site) / Vascular Breakthroughs (research support)Recruiting
  • Palm Beach Heart and VascularRecruiting
  • Bradenton CardiologyRecruiting
  • First Coast Cardiovascular InstituteRecruiting
  • South Miami HospitalRecruiting
  • Baptist Hospital of MiamiRecruiting
  • Surgical Specialists of OcalaRecruiting
  • Ansaarie Cardiac & Endovascular Center of ExcellenceRecruiting
  • Midwest Cardiovascular InstituteRecruiting
  • Midwest Cardiovascular Research FoundationRecruiting
  • Cardiovascular Institute of the SouthRecruiting
  • Ochsner HealthRecruiting
  • Massachusetts General HospitalRecruiting
  • Vascular Care Group (site) / Vascular Breakthroughs (research support)Recruiting
  • Advanced Cardiac and Vascular Centers for Amputation PreventionRecruiting
  • Advanced Vascular SurgeryRecruiting
  • Eastlake Cardiovascular PCRecruiting
  • University of MissouriRecruiting
  • Advanced Heart and Vascular Institute of HunterdonRecruiting
  • Holy Name Medical CenterRecruiting
  • Columbia University Irving Medical CenterRecruiting
  • Novant Health Heart & Vascular InstituteRecruiting
  • Ohio HealthRecruiting
  • The Miriam HospitalRecruiting
  • Medical University of South Carolina (MUSC)Recruiting
  • Prisma HealthRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • El Paso Cardiology AssociatesRecruiting
  • Texas Tech University Health Sciences CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bare Temporary Spur Stent System

Arm Description

Treatment with the Temporary Bare Spur Stent System (Spur Stent System).

Outcomes

Primary Outcome Measures

Primary Efficacy Endpoint: Technical Success of the Bare Temporary Spur Stent
Technical Success is defined as <30% residual stenosis in subjects treated with the Bare Temporary Spur Stent System
Co-Primary Safety Endpoint: Freedom from the occurrence of major adverse limb events (MALE)
Number of participants with freedom from the occurrence of major adverse limb events (MALE) [evaluated at 30 days post procedure] and peri-operative death (POD) [defined as all-cause mortality within 30 days post procedure]. MALE is defined as: Above-the-ankle amputation of the index limb Major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving the infrapopliteal arteries.

Secondary Outcome Measures

Full Information

First Posted
April 15, 2022
Last Updated
September 28, 2023
Sponsor
ReFlow Medical, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05358353
Brief Title
A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)
Acronym
DEEPER REVEAL
Official Title
A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 22, 2024 (Anticipated)
Study Completion Date
October 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ReFlow Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, multicenter, single arm study designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Critical Limb Ischemia
Keywords
Peripheral Arterial Disease, Critical Limb Ischemia, Infrapopliteal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bare Temporary Spur Stent System
Arm Type
Experimental
Arm Description
Treatment with the Temporary Bare Spur Stent System (Spur Stent System).
Intervention Type
Device
Intervention Name(s)
Bare Temporary Spur Stent System
Intervention Description
Treatment of qualifying infrapopliteal arteries with the Bare Temporary Spur Stent System, in subjects with critical limb ischemia.
Primary Outcome Measure Information:
Title
Primary Efficacy Endpoint: Technical Success of the Bare Temporary Spur Stent
Description
Technical Success is defined as <30% residual stenosis in subjects treated with the Bare Temporary Spur Stent System
Time Frame
At the end of the Index Procedure
Title
Co-Primary Safety Endpoint: Freedom from the occurrence of major adverse limb events (MALE)
Description
Number of participants with freedom from the occurrence of major adverse limb events (MALE) [evaluated at 30 days post procedure] and peri-operative death (POD) [defined as all-cause mortality within 30 days post procedure]. MALE is defined as: Above-the-ankle amputation of the index limb Major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving the infrapopliteal arteries.
Time Frame
30 days post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Pre-Procedure Inclusion Criteria: Subject willing and able to provide informed consent and able to comply with the study protocol and follow up. Subjects who are unable to sign due to a physical limitation may have a witness, including a family member, sign on their behalf. Life expectancy greater than 1 year in the investigator's opinion. Male or non-pregnant female ≥18 years of age at time of consent. Subjects must have chronic (greater than 14 days) symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 4-5, rest pain (R 4), and/or minor tissue loss (R5), that in the opinion of the investigator are not amenable to conservative medical therapy and require endovascular intervention for alleviation of symptoms and tissue preservation. For subjects with bilateral disease, planned treatment of the contralateral limb must either be performed greater than or equal to 3 days prior to the index procedure or greater than or equal to 7 days following the index procedure. Angiographic Inclusion Criteria: Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels, with target lesion that can be successfully crossed via the true lumen with a guidewire (no subintimal crossing). Iliac, SFA and popliteal inflow lesions can be treated using standard of care during the index procedure or greater than or equal to 3 days prior. Note: Inflow lesions treated intraprocedure must be treated first, prior to consideration of treatment of infrapopliteal lesions. Treatment of in-stent restenosis in inflow treatment is permitted, provided that stents are not fractured or otherwise compromised. Distal embolic protection is strongly encouraged in cases where atherectomy is used. Inflow lesions must have a healthy vessel segment of greater than 30 mm between the study lesion and the treated segment, defined as less than 50% stenosis without aneurysmal segments. Inflow treatment must be successful, prior to treatment of the target lesion, resulting in stenosis less than or equal to 30%, without resulting flow limiting dissection, thrombus, or aneurysm by angiography. Target vessel(s) reconstitute(s) at or above the ankle, with the target treated segment ending at least 10 mm above the ankle joint. Note: If the anterior tibial or posterior tibial arteries are treated, there must be inline flow to the foot. If the peroneal artery is treated, there must be at least one collateral supplying the foot. In all cases, patent runoff (no lesions with greater than 50% stenosis) must be present via the dorsalis pedis and/or plantar arteries Target lesion must be located in the tibial arteries. If vessel sizing remains appropriate, treatment may extend into the distal popliteal (P3) segment. Target vessel reference diameter is measured to be between 2.5 to 4.5 mm in diameter assessed by one of the following methods after successful completion of guidewire crossing of the lesion site: Intravascular Ultrasound (IVUS) (primary) Visual estimate using Angiography (secondary) Target lesion length is less than or equal to 210mm in length. Tandem lesions that are less than or equal to 4 cm should be treated as one lesion. Multiple discrete lesions may be treated provided cumulative length is less than or equal to 210 mm. Successful pre-dilatation of the target lesion defined as resulting in stenosis less than or equal to 50% and/or inner lumen diameter greater than or equal to 2.0 mm in diameter, without resulting flow limiting dissection, thrombus, or aneurysm by angiography prior to the insertion of the Bare Temporary Spur Stent System. Only one limb and one contiguous vessel may be enrolled per subject. If required, a second modality may be used for treatment in the non-target infrapopliteal vessel. Note: Distal embolic protection is strongly recommended in cases using atherectomy. Treatment of the target vessel/lesion may be performed only if treatment of the non-target lesion is successful without resulting flow limiting (Type D or greater) dissection, thrombus, or aneurysm by angiography. Treatment of non-target lesions must be parallel to, and not contiguous with, the target lesion. If pre-screening with duplex ultrasound, angiography, CTA, or MRA has been performed less than or equal to 365 days prior to the procedure, intra-procedure angiography of the aorto-iliac vasculature is not required, however, the femoropopliteal inflow must still be imaged using angiography during the index procedure. Retrograde access (in the infrapopliteal arteries) is permitted for lesion crossing; however, the Bare Temporary Spur Stent System must be deployed from antegrade (above the knee, either ipsilateral or contralateral) access. Pre-procedure Exclusion Criteria: Subject unwilling or unlikely to comply with the 1-year duration of the study in the opinion of the investigator. Subject is pregnant or planning to become pregnant during the course of the trial. Subject has an active systemic infection that is not controlled at the time of the procedure, including septicemia or bacteremia. Subject has osteomyelitis proximal to the phalanges. Osteomyelitis in the digit(s) of the target foot is permitted. Wounds must be confined to the foot below the ankle. Heel wounds are excluded. Planned major (above the ankle) amputation of the target limb. A planned or previous minor (trans metatarsal amputation or digit amputation) is permitted. Recent myocardial infarction or stroke less than 90 days prior to the index procedure. Symptomatic acute heart failure NYHA class III or greater. Impaired renal function (eGFR less than or equal to 25 mL/min) within 30 days of procedure or end stage renal disease on dialysis. Inability to tolerate dual antiplatelet and/or anticoagulation therapy. Known allergies or sensitivities to heparin, antiplatelet drugs, other anticoagulant therapies which could not be substituted, or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure. The subject is currently enrolled in another investigational device or drug trial that interferes with the study endpoints. Known allergy to nitinol or nickel. Bypass surgery of the target vessel(s). Prior bypass above the level of the infrapopliteal arteries is permitted. Angiographic Exclusion Criteria Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion. Inflow must also be free of aneurysmal segments. Fractured or otherwise compromised stents in the target vessel or inflow vessel. In-stent restenosis in the target vessel. Previous treatment of inflow lesions performed less than or equal to 7 days prior to the index procedure. Previous treatment of the target vessel less than or equal to 90 days prior to index procedure. Angiographic evidence of thrombus within target limb. Extremely severe calcification that, in the investigator's opinion, would not be amenable to PTA. Type D dissections or greater incurred during CTO crossing (see Appendix I for definitions). Significant (greater than or equal to 50%) stenosis of inflow arteries or unsuccessful treatment of inflow lesions. Distance from access to lesion is too long for a 135 cm working length of the Bare Temporary Spur Stent System catheter.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolyn Mascho
Phone
(616) 802-8575
Email
cmascho@reflowmedical.com
Facility Information:
Facility Name
St. Bernards Heart and Vascular
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Max Arroyo
First Name & Middle Initial & Last Name & Degree
Max Arroyo
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Cawich
First Name & Middle Initial & Last Name & Degree
Ian Cawich
Facility Name
Vascular & Interventional Specialist of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhavraj Khalsa
First Name & Middle Initial & Last Name & Degree
Bhavraj Khalsa
Facility Name
Vascular Care Connecticut (site) / Vascular Breakthroughs (research support)
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Gagne
First Name & Middle Initial & Last Name & Degree
Paul Gagne
Facility Name
Palm Beach Heart and Vascular
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33436
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Michael
First Name & Middle Initial & Last Name & Degree
Paul Michael
Facility Name
Bradenton Cardiology
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay Mathews
First Name & Middle Initial & Last Name & Degree
Jay Mathews
Facility Name
First Coast Cardiovascular Institute
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yazan Khatib
First Name & Middle Initial & Last Name & Degree
Yazan Khatib
Facility Name
South Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Constantino Pena
First Name & Middle Initial & Last Name & Degree
Constantino Pena, MD
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Constantino Pena
First Name & Middle Initial & Last Name & Degree
Constantino Pena
Facility Name
Surgical Specialists of Ocala
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravi Chandra
First Name & Middle Initial & Last Name & Degree
Ravi Chandra
Facility Name
Ansaarie Cardiac & Endovascular Center of Excellence
City
Palatka
State/Province
Florida
ZIP/Postal Code
32177
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imran Ansaarie
First Name & Middle Initial & Last Name & Degree
Imran Ansaarie
Facility Name
Midwest Cardiovascular Institute
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Goodwin
First Name & Middle Initial & Last Name & Degree
Mark Goodwin
Facility Name
Midwest Cardiovascular Research Foundation
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Shammas
First Name & Middle Initial & Last Name & Degree
Nicolas Shammas
Facility Name
Cardiovascular Institute of the South
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ankur Lodha
First Name & Middle Initial & Last Name & Degree
Ankur Lodha
Facility Name
Ochsner Health
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zola N'Dandu
First Name & Middle Initial & Last Name & Degree
Zola N'Dandu
Facility Name
Massachusetts General Hospital
City
Somerville
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Dua
First Name & Middle Initial & Last Name & Degree
Anahita Dua
Facility Name
Vascular Care Group (site) / Vascular Breakthroughs (research support)
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
02482
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larry Garcia
First Name & Middle Initial & Last Name & Degree
Larry Garcia
Facility Name
Advanced Cardiac and Vascular Centers for Amputation Prevention
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihad Mustapha, MD
Facility Name
Advanced Vascular Surgery
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Ranger
First Name & Middle Initial & Last Name & Degree
William Ranger
Facility Name
Eastlake Cardiovascular PC
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Davis
First Name & Middle Initial & Last Name & Degree
Thomas Davis
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Bath
First Name & Middle Initial & Last Name & Degree
Jonathan Bath
Facility Name
Advanced Heart and Vascular Institute of Hunterdon
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrey Espinoza
First Name & Middle Initial & Last Name & Degree
Andrey Espinoza
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Rundback
First Name & Middle Initial & Last Name & Degree
John Rundback
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sahil Parikh
First Name & Middle Initial & Last Name & Degree
Sahil Parikh
Facility Name
Novant Health Heart & Vascular Institute
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Delgado
First Name & Middle Initial & Last Name & Degree
Gabriel Delgado
Facility Name
Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Phillips
First Name & Middle Initial & Last Name & Degree
John Phillips
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Soukas
First Name & Middle Initial & Last Name & Degree
Peter Soukas
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharee Wright
First Name & Middle Initial & Last Name & Degree
Sharee Wright
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sagar Gandhi
First Name & Middle Initial & Last Name & Degree
Sagar Gandhi
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Clair
First Name & Middle Initial & Last Name & Degree
Daniel Clair
Facility Name
El Paso Cardiology Associates
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laiq Raja
First Name & Middle Initial & Last Name & Degree
Laiq Raja
Facility Name
Texas Tech University Health Sciences Center
City
Odessa
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mac Ansari
First Name & Middle Initial & Last Name & Degree
Mac Ansari

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)

We'll reach out to this number within 24 hrs