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FORWARD PAD IDE Study With the Shockwave Mini S IVL Catheter (FORWARD PAD)

Primary Purpose

Peripheral Arterial Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intravascular Lithotripsy
Sponsored by
Shockwave 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 Intravascular Lithotripsy

Eligibility Criteria

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

General Inclusion Criteria Age of subject is ≥ 18 years. Subject is able and willing to comply with all assessments in the study. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form. Estimated life expectancy > 1 year. Rutherford Clinical Category 2, 3, 4 or 5 of the target limb(s). Angiographic Inclusion Criteria One or two target lesion(s) located in a native de novo superficial femoral, popliteal or infrapopliteal artery (above the ankle joint), in one or both limbs. Target lesion reference vessel diameter (RVD) between 2.0 mm and 7.0 mm by investigator visual estimate. Target lesion stenosis ≥70% (for vessels below the knee defined as P3 to the ankle joint) or ≥90% (for vessels above the knee) by investigator visual estimate. Target lesion length is ≤150 mm by investigator visual estimate. Target lesion can be all or part of the 150 mm treated zone. Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length. General Exclusion Criteria Rutherford Clinical Category 0, 1 and 6 (target limb). History of endovascular or surgical procedure on the target limb within the last 30 days or planned within 30 days of the index procedure, with the exception of toe amputation. Note: inflow treatment of non-target lesions is allowed providing successful treatment. Subject in whom antiplatelet or anticoagulant therapy is contraindicated. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated. Subject has known allergy to urethane, nylon, or silicone. Myocardial infarction within 60 days prior to enrollment. History of stroke within 60 days prior to enrollment. Subject has acute or chronic renal disease with eGFR <30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy. Subject is pregnant or nursing. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint. Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment. Covid-19 diagnosis within 30 days. Planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesion(s) during the index procedure. Planned major amputation of target limb. Acute limb ischemia. Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot). Subject already enrolled into this study. Angiographic Exclusion Criteria Failure to successfully treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries, defined as ≤30% residual stenosis with no serious angiographic complications (e.g. embolism). Failure to successfully treat significant non-target infra-popliteal lesions, if treated prior to treatment of target lesion(s). Successful treatment is defined as obtaining ≤50% residual stenosis with no serious angiographic complications (e.g., embolism). Target lesion includes in-stent restenosis. Evidence of aneurysm or thrombus in target vessel. No calcium or mild calcium in the target lesion. Target lesion within native or synthetic vessel grafts. Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations.

Sites / Locations

  • Advanced Heart and Vein CenterRecruiting
  • HCA Florida Blake HospitalRecruiting
  • Midwest Cardiovascular Research FoundationRecruiting
  • MedStar Montgomery Medical CenterRecruiting
  • North Mississippi Medical CenterRecruiting
  • NYU Langone HealthRecruiting
  • Ascension St. John Jane Phillips HosptialRecruiting
  • The Miriam HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

JAVELIN Study Catheter

Arm Description

The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.

Outcomes

Primary Outcome Measures

Primary Safety Endpoint - Major Adverse Events (MAE) at 30 days
Major Adverse Events (MAE) at 30 days defined as a composite of: Cardiovascular death Clinically-driven target lesion revascularization (CD-TLR) Unplanned target limb major amputation (above the ankle)
Primary Effectiveness Endpoint - Technical Success
Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion as assessed by angiographic core lab.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2023
Last Updated
October 11, 2023
Sponsor
Shockwave Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05858905
Brief Title
FORWARD PAD IDE Study With the Shockwave Mini S IVL Catheter
Acronym
FORWARD PAD
Official Title
Forward-Shifted Intravascular Lithotripsy (IVL) Technology in a Prospective, Multi-center, Single-arm Investigational Device Exemption (IDE) Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shockwave 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
The FORWARD PAD IDE Study is a prospective, multi-center, single-arm investigational device exemption study, conducted to assess the safety and effectiveness of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Intravascular Lithotripsy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
JAVELIN Study Catheter
Arm Type
Experimental
Arm Description
The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
Intervention Type
Device
Intervention Name(s)
Intravascular Lithotripsy
Intervention Description
The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
Primary Outcome Measure Information:
Title
Primary Safety Endpoint - Major Adverse Events (MAE) at 30 days
Description
Major Adverse Events (MAE) at 30 days defined as a composite of: Cardiovascular death Clinically-driven target lesion revascularization (CD-TLR) Unplanned target limb major amputation (above the ankle)
Time Frame
30 Days
Title
Primary Effectiveness Endpoint - Technical Success
Description
Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion as assessed by angiographic core lab.
Time Frame
Peri-Procedural

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
General Inclusion Criteria Age of subject is ≥ 18 years. Subject is able and willing to comply with all assessments in the study. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form. Estimated life expectancy > 1 year. Rutherford Clinical Category 2, 3, 4 or 5 of the target limb(s). Angiographic Inclusion Criteria One or two target lesion(s) located in a native de novo superficial femoral, popliteal or infrapopliteal artery (above the ankle joint), in one or both limbs. Target lesion reference vessel diameter (RVD) between 2.0 mm and 7.0 mm by investigator visual estimate. Target lesion stenosis ≥70% (for vessels below the knee defined as P3 to the ankle joint) or ≥90% (for vessels above the knee) by investigator visual estimate. Target lesion length is ≤150 mm by investigator visual estimate. Target lesion can be all or part of the 150 mm treated zone. Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length. General Exclusion Criteria Rutherford Clinical Category 0, 1 and 6 (target limb). History of endovascular or surgical procedure on the target limb within the last 30 days or planned within 30 days of the index procedure, with the exception of toe amputation. Note: inflow treatment of non-target lesions is allowed providing successful treatment. Subject in whom antiplatelet or anticoagulant therapy is contraindicated. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated. Subject has known allergy to urethane, nylon, or silicone. Myocardial infarction within 60 days prior to enrollment. History of stroke within 60 days prior to enrollment. Subject has acute or chronic renal disease with eGFR <30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy. Subject is pregnant or nursing. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint. Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment. Covid-19 diagnosis within 30 days. Planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesion(s) during the index procedure. Planned major amputation of target limb. Acute limb ischemia. Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot). Subject already enrolled into this study. Angiographic Exclusion Criteria Failure to successfully treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries, defined as ≤30% residual stenosis with no serious angiographic complications (e.g. embolism). Failure to successfully treat significant non-target infra-popliteal lesions, if treated prior to treatment of target lesion(s). Successful treatment is defined as obtaining ≤50% residual stenosis with no serious angiographic complications (e.g., embolism). Target lesion includes in-stent restenosis. Evidence of aneurysm or thrombus in target vessel. No calcium or mild calcium in the target lesion. Target lesion within native or synthetic vessel grafts. Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bhavana Shivakumar
Phone
248-266-5963
Email
bshivakumar@shockwavemedical.com
Facility Information:
Facility Name
Advanced Heart and Vein Center
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80023
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihan Shah
Phone
720-838-1437
Email
jihan.shah2@outlook.com
First Name & Middle Initial & Last Name & Degree
Rizwan Shahid
Phone
202-500-1486
Email
rizwanshahid@gmail.com
First Name & Middle Initial & Last Name & Degree
Ehrin Armstrong, MD
Facility Name
HCA Florida Blake Hospital
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Pirozzolo
Email
nicole.pirozzolo@novaclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Iftekhar Baig, DO
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
Gail Shammas
Email
shammasg@mcrfmd.com
First Name & Middle Initial & Last Name & Degree
Nicolas Shammas, MD
Facility Name
MedStar Montgomery Medical Center
City
Olney
State/Province
Maryland
ZIP/Postal Code
20832
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendra Green
Email
kendra.s.green@medstar.net
First Name & Middle Initial & Last Name & Degree
Kyle Reynolds, MD
Facility Name
North Mississippi Medical Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber Jernigan
Email
anschmitz@nmhs.net
First Name & Middle Initial & Last Name & Degree
Barry Bertolet, MD
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Telegina
Email
anna.telegina@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Anvar Babaev, MD
Facility Name
Ascension St. John Jane Phillips Hosptial
City
Bartlesville
State/Province
Oklahoma
ZIP/Postal Code
74006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Harris
Email
mary.harris5@ascension.org
First Name & Middle Initial & Last Name & Degree
Anderson Mehrle, MD
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
Lina Felix
Phone
401-793-4105
Email
lfelix@lifespan.org
First Name & Middle Initial & Last Name & Degree
Peter Soukas, MD

12. IPD Sharing Statement

Learn more about this trial

FORWARD PAD IDE Study With the Shockwave Mini S IVL Catheter

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