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The DETOUR2 Clinical Study

Primary Purpose

Peripheral Arterial Disease

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PQ Bypass System
Sponsored by
PQ Bypass, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in the study:

General Inclusion Criteria

  1. Age > 18 and ≤ 90 years of age.
  2. Willing and able to provide informed consent.
  3. Subject is willing to undergo all follow-up assessments according to the specified schedule over 36 months.

    Clinical Inclusion Criteria

  4. Chronic, symptomatic lower limb ischemia defined as Rutherford clinical categories 3, 4, or 5.
  5. Venous Clinical Severity Score < 3.
  6. Subject is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair.

    Angiographic Inclusion Criteria

  7. Symptomatic femoropopliteal chronic total occlusions ≥ 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or Symptomatic femoropopliteal lesions ≥ 24 cm (total lesion length) that can include a chronic total occlusion or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C), by investigator visual assessment.
  8. Reference vessel diameter ≥ 4.5 and ≤ 6.7 mm, by investigator visual assessment.
  9. Subject has a patent popliteal artery (<50% stenosis) distal to the landing zone
  10. Able to successfully access the SFA origin for entry of the crossing device.
  11. At least one patent infrapopliteal vessel (<50% stenosis) with run-off to the ankle or foot.
  12. A significant stenosis (≥ 50%) or occlusion of an ipsilateral, inflow artery (e.g. aortoiliac, common femoral) must be successfully treated (use of investigational treatment prohibited) prior to treatment of the target lesion. Successful treatment is defined as no complications and less than 30% residual stenosis following intervention.

General Exclusion Criteria

  1. Participating in another investigational clinical study.
  2. Anticipated life expectancy less than 1 year or medical comorbid condition(s) that could limit the subject's ability to comply with the requirements of the trial.
  3. 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.

    Clinical Exclusion Criteria

  4. History of deep vein thrombosis on either limb.
  5. Thrombophlebitis, within the previous 30 days.
  6. 6. Planned major amputation of the target limb, including minor amputation (above the ankle).
  7. Prior distal amputation (above the transmetatarsal) of the target limb.
  8. Known or suspected active infection at the time of the procedure (e.g., WIfI foot infection grade 3: Severe infection. Local infection with systemic inflammatory response syndrome [SIRS])
  9. Rutherford clinical category 0, 1, 2 or 6.
  10. Has acute or chronic renal disease with GFR ≤ 30 ml/min per 1.73 m2 and/or elevated serum creatinine >2.5mg/dL (220µmol/L) or on dialysis.
  11. Known hypersensitivity/allergy to the investigational devices and/or required pharmacotherapy that cannot be safely managed.
  12. Morbid obesity that does not allow for safe vascular access or imaging.
  13. Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR > 1.8.
  14. Requires coronary or peripheral procedure within 30 days prior to or planned within 30 days post treatment of the target lesion.
  15. Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 3 months.
  16. Subject is pregnant or breast-feeding. Angiographic Exclusion Criteria
  17. Stent within 3 cm of SFA ostium.
  18. Previous bypass surgery on the target limb.
  19. Subject has significant disease or obstruction (≥50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as ≤30% residual stenosis, without complication)
  20. Presence of aneurysm or acute thrombus in the target limb.
  21. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.

Sites / Locations

  • HonorHealth
  • St. Bernard's Medical Center
  • Arkansas Heart Hospital
  • Bay Area Vein and Vascular
  • Community Hospital of the Monterrey Peninsula
  • Advanced Cardiovascular Specialists
  • Denver VA Medical Center
  • The Vascular Experts
  • First Coast Cardiovascular Institute
  • Baptist Hospital Miami
  • Christie Clinic
  • AMITA Health Alexian Brothers Medical Center
  • Prairie Education and Research Cooperative
  • MedStar Health Research Institute
  • Massachusetts General Hospital
  • McLaren Bay Region Hospital
  • Advanced Cardiac and Vascular Amputation Prevention Centers
  • Cardiac & Vascular Research Center of Nothern Michigan
  • Cardiology Associates of North Mississippi
  • New Mexico Heart Institute
  • New York-Presbyterian / Columbia University Medical Center
  • North Caroline Hearth and Vascular- University of North Carolina Rex
  • The Christ Hospital - The Carl & Edyth Lindner Center for Research & Education
  • Cleveland Clinical Foundation
  • Miriam Hospital
  • Greenville Health System
  • North Dallas Research Associates
  • Texas Tech
  • Sentara Norfolk General Hospital
  • Aurora Research Institute
  • Klinikum Hochsauerland GmbH
  • Cardioangiologisches Centrum Bethanien
  • Universität Leipzig
  • Pauls Stradins Clinical University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-Arm

Arm Description

The PQ Bypass system is used during a minimally invasive procedure to place stent grafts in the peripheral vasculature to improve blood flow.

Outcomes

Primary Outcome Measures

Primary Effectiveness Endpoint
The absence of clinically-driven target lesion revascularization and/or absence of recurrent target lesion diameter stenosis >50% by imaging (e.g., duplex ultrasound (peak systolic velocity ratio of >2.5) or invasive angiography) with the stent or immediately 1 cm above or below the treated segment.). When both modalities are available, angiography takes precedence.
Primary Safety Endpoint
Freedom from a major adverse event (MAE) at 30 days post-procedure defined as any occurrence of the following events: Death, Clinically-Driven Target Lesion Revascularization (CD-TLR), Major Amputation of(above the Treated Limb,ankle), Symptomatic Deep Vein Thrombosis (DVT), Pulmonary Embolism, or procedure-related bleeding requiring any transfusion of packed red blood cells or surgery.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2017
Last Updated
March 17, 2023
Sponsor
PQ Bypass, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03119233
Brief Title
The DETOUR2 Clinical Study
Official Title
The Detour Endovascular Technique for Long OcclUsive Fem-pop Revascularization - 2 Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 13, 2017 (Actual)
Primary Completion Date
December 22, 2021 (Actual)
Study Completion Date
November 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PQ Bypass, 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
Prospective, single-arm, multi-center, international clinical investigation to evaluate the safety and effectiveness of the PQ Bypass System to access, deliver guidewires, and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.
Detailed Description
The DETOUR2 study is a prospective, single-arm, multi-center, international, non-randomized, safety and effectiveness clinical investigation of the PQ Bypass system. The PQ Bypass System is intended to improve blood flow in patients with symptomatic peripheral arterial disease due to symptomatic femoropopliteal chronic total occlusions ≥ 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or Symptomatic femoropopliteal lesions ≥ 24 cm (total lesion length) that can include a chronic total occlusion or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C), with reference vessel diameters ranging from 5.0 - 6.7 mm, by investigator visual assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial 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
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-Arm
Arm Type
Experimental
Arm Description
The PQ Bypass system is used during a minimally invasive procedure to place stent grafts in the peripheral vasculature to improve blood flow.
Intervention Type
Device
Intervention Name(s)
PQ Bypass System
Intervention Description
Intended use from CLN114 Rev F (CLN114 is the DETOUR2 protocol) The PQ Bypass System is intended to improve blood flow in patients with peripheral arterial disease in symptomatic femoropopliteal lesions due to chronic total occlusions ≥ 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or total lesion lengths ≥24 cm that can include chronic total occlusions or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C).
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint
Description
The absence of clinically-driven target lesion revascularization and/or absence of recurrent target lesion diameter stenosis >50% by imaging (e.g., duplex ultrasound (peak systolic velocity ratio of >2.5) or invasive angiography) with the stent or immediately 1 cm above or below the treated segment.). When both modalities are available, angiography takes precedence.
Time Frame
12 months
Title
Primary Safety Endpoint
Description
Freedom from a major adverse event (MAE) at 30 days post-procedure defined as any occurrence of the following events: Death, Clinically-Driven Target Lesion Revascularization (CD-TLR), Major Amputation of(above the Treated Limb,ankle), Symptomatic Deep Vein Thrombosis (DVT), Pulmonary Embolism, or procedure-related bleeding requiring any transfusion of packed red blood cells or surgery.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in the study: General Inclusion Criteria Age > 18 and ≤ 90 years of age. Willing and able to provide informed consent. Subject is willing to undergo all follow-up assessments according to the specified schedule over 36 months. Clinical Inclusion Criteria Chronic, symptomatic lower limb ischemia defined as Rutherford clinical categories 3, 4, or 5. Venous Clinical Severity Score < 3. Subject is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair. Angiographic Inclusion Criteria Symptomatic femoropopliteal chronic total occlusions ≥ 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or Symptomatic femoropopliteal lesions ≥ 24 cm (total lesion length) that can include a chronic total occlusion or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C), by investigator visual assessment. Reference vessel diameter ≥ 4.5 and ≤ 6.7 mm, by investigator visual assessment. Subject has a patent popliteal artery (<50% stenosis) distal to the landing zone Able to successfully access the SFA origin for entry of the crossing device. At least one patent infrapopliteal vessel (<50% stenosis) with run-off to the ankle or foot. A significant stenosis (≥ 50%) or occlusion of an ipsilateral, inflow artery (e.g. aortoiliac, common femoral) must be successfully treated (use of investigational treatment prohibited) prior to treatment of the target lesion. Successful treatment is defined as no complications and less than 30% residual stenosis following intervention. General Exclusion Criteria Participating in another investigational clinical study. Anticipated life expectancy less than 1 year or medical comorbid condition(s) that could limit the subject's ability to comply with the requirements of the trial. 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. Clinical Exclusion Criteria History of deep vein thrombosis on either limb. Thrombophlebitis, within the previous 30 days. 6. Planned major amputation of the target limb, including minor amputation (above the ankle). Prior distal amputation (above the transmetatarsal) of the target limb. Known or suspected active infection at the time of the procedure (e.g., WIfI foot infection grade 3: Severe infection. Local infection with systemic inflammatory response syndrome [SIRS]) Rutherford clinical category 0, 1, 2 or 6. Has acute or chronic renal disease with GFR ≤ 30 ml/min per 1.73 m2 and/or elevated serum creatinine >2.5mg/dL (220µmol/L) or on dialysis. Known hypersensitivity/allergy to the investigational devices and/or required pharmacotherapy that cannot be safely managed. Morbid obesity that does not allow for safe vascular access or imaging. Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR > 1.8. Requires coronary or peripheral procedure within 30 days prior to or planned within 30 days post treatment of the target lesion. Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 3 months. Subject is pregnant or breast-feeding. Angiographic Exclusion Criteria Stent within 3 cm of SFA ostium. Previous bypass surgery on the target limb. Subject has significant disease or obstruction (≥50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as ≤30% residual stenosis, without complication) Presence of aneurysm or acute thrombus in the target limb. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihad Mustapha, MD
Organizational Affiliation
Advanced Cardiac and Vascular Amputation Prevention Centers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sean Lyden, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
HonorHealth
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
St. Bernard's Medical Center
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Bay Area Vein and Vascular
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
Community Hospital of the Monterrey Peninsula
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Advanced Cardiovascular Specialists
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Denver VA Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
The Vascular Experts
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
Facility Name
First Coast Cardiovascular Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Baptist Hospital Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Christie Clinic
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61822
Country
United States
Facility Name
AMITA Health Alexian Brothers Medical Center
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Prairie Education and Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
MedStar Health Research Institute
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
McLaren Bay Region Hospital
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48708
Country
United States
Facility Name
Advanced Cardiac and Vascular Amputation Prevention Centers
City
Grandville
State/Province
Michigan
ZIP/Postal Code
49418
Country
United States
Facility Name
Cardiac & Vascular Research Center of Nothern Michigan
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Cardiology Associates of North Mississippi
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
New Mexico Heart Institute
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
New York-Presbyterian / Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
North Caroline Hearth and Vascular- University of North Carolina Rex
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
The Christ Hospital - The Carl & Edyth Lindner Center for Research & Education
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinical Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
North Dallas Research Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Texas Tech
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79409
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Aurora Research Institute
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Facility Name
Klinikum Hochsauerland GmbH
City
Arnsberg
ZIP/Postal Code
59759
Country
Germany
Facility Name
Cardioangiologisches Centrum Bethanien
City
Frankfurt
Country
Germany
Facility Name
Universität Leipzig
City
Leipzig
ZIP/Postal Code
04203
Country
Germany
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia

12. IPD Sharing Statement

Plan to Share IPD
No

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The DETOUR2 Clinical Study

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