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DETOUR I Clinical Study

Primary Purpose

Peripheral Arterial Disease

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PQ Bypass System for Femoropopliteal Bypass
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:

  • Willing and able to provide informed consent
  • Age 18 or older
  • Rutherford Classification of 3-5
  • Patent iliac and femoral arteries/veins and access vessels, of sufficient size and morphology (including tortuosity), to allow endovascular access with 8 Fr. introducer sheath

  • Femoro-popliteal lesions ≥10 cm in length considered to be:

    • Chronic total occlusion (100% stenosis)
    • Diffuse stenosis (>50% stenosis) with moderate to heavy calcification
    • In-stent restenosis (>50% stenosis)
  • Proximal and distal target vessels are 5.4-7.0 mm in diameter
  • Orifice and proximal 1 cm of SFA is patent
  • Patent popliteal artery 3 cm proximal to tibial plateau
  • At least 1 patent tibial artery to the foot
  • Patent femoral vein ≥ 10 mm in diameter or duplicate femoral vein
  • Subject has > one year life expectancy

Exclusion Criteria:

  • Bypass length required > 30 cm
  • History of deep vein thrombosis
  • Has a known hypersensitivities, allergies or contraindications to: nitinol, PTFE; aspirin, heparin, antiplatelet, anticoagulant or thrombolytic therapy; or anticoagulation or contrast media that is not amenable to pre-treatment;
  • Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 12 months
  • Pregnant or nursing
  • Untreated flow-limiting aortoiliac occlusive disease
  • Has renal failure (eGFR < 30mL/min)
  • Major distal amputation (above the transmetatarsal) in the study or non-study limb
  • Patient has had a revascularization procedure on the target limb within 30 days
  • Patient has a planned amputation of the target limb
  • Previous bypass surgery on the target limb
  • Patient is participating in another clinical study for which follow-up is currently on going.
  • Patient has a condition that in the view of the investigator precludes participation in this study

Sites / Locations

  • Universidad Católica de Chile
  • University of Leipzig Medical Centre
  • Ospedale San Raffaele
  • Stradins University Hospital
  • Vascular Service
  • Gdansk Medical University
  • Poznan University of Medical Sciences
  • Institute of Haematology Medicine Indira Gandhi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm study

Arm Description

PQ Bypass System for Femoropopliteal Bypass to complete percutaneous fem-pop bypass

Outcomes

Primary Outcome Measures

Primary Performance Endpoint (Rate of primary patency)
Rate of primary patency. Primary patency defined as: no evidence of clinically significant stenosis (≥50%) within the stent graft or immediately above or below the treated arterial segment based on duplex ultrasound (systolic velocity ratio of >2.5).

Secondary Outcome Measures

Full Information

First Posted
June 11, 2015
Last Updated
June 24, 2019
Sponsor
PQ Bypass, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02471638
Brief Title
DETOUR I Clinical Study
Official Title
PQ Bypass Systems for Femoropopliteal Bypass II (PQB 4 FP II)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2020 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To assess the safety and performance of the PQ Bypass System to access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
Detailed Description
Prospective, single-arm, multi-center, international, non-randomized, pre-market, safety and effectiveness clinical investigation evaluating the PQ Bypass Systems to access, deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.

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
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm study
Arm Type
Experimental
Arm Description
PQ Bypass System for Femoropopliteal Bypass to complete percutaneous fem-pop bypass
Intervention Type
Device
Intervention Name(s)
PQ Bypass System for Femoropopliteal Bypass
Intervention Description
To access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
Primary Outcome Measure Information:
Title
Primary Performance Endpoint (Rate of primary patency)
Description
Rate of primary patency. Primary patency defined as: no evidence of clinically significant stenosis (≥50%) within the stent graft or immediately above or below the treated arterial segment based on duplex ultrasound (systolic velocity ratio of >2.5).
Time Frame
6 months

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: Willing and able to provide informed consent Age 18 or older Rutherford Classification of 3-5 Patent iliac and femoral arteries/veins and access vessels, of sufficient size and morphology (including tortuosity), to allow endovascular access with 8 Fr. introducer sheath Femoro-popliteal lesions ≥10 cm in length considered to be: Chronic total occlusion (100% stenosis) Diffuse stenosis (>50% stenosis) with moderate to heavy calcification In-stent restenosis (>50% stenosis) Proximal and distal target vessels are 5.4-7.0 mm in diameter Orifice and proximal 1 cm of SFA is patent Patent popliteal artery 3 cm proximal to tibial plateau At least 1 patent tibial artery to the foot Patent femoral vein ≥ 10 mm in diameter or duplicate femoral vein Subject has > one year life expectancy Exclusion Criteria: Bypass length required > 30 cm History of deep vein thrombosis Has a known hypersensitivities, allergies or contraindications to: nitinol, PTFE; aspirin, heparin, antiplatelet, anticoagulant or thrombolytic therapy; or anticoagulation or contrast media that is not amenable to pre-treatment; Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 12 months Pregnant or nursing Untreated flow-limiting aortoiliac occlusive disease Has renal failure (eGFR < 30mL/min) Major distal amputation (above the transmetatarsal) in the study or non-study limb Patient has had a revascularization procedure on the target limb within 30 days Patient has a planned amputation of the target limb Previous bypass surgery on the target limb Patient is participating in another clinical study for which follow-up is currently on going. Patient has a condition that in the view of the investigator precludes participation in this study
Facility Information:
Facility Name
Universidad Católica de Chile
City
Santiago
Country
Chile
Facility Name
University of Leipzig Medical Centre
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Stradins University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Vascular Service
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Gdansk Medical University
City
Gdańsk
Country
Poland
Facility Name
Poznan University of Medical Sciences
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Institute of Haematology Medicine Indira Gandhi
City
Warsaw
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33429092
Citation
Schneider PA, Krievins DK, Halena G, Schmidt A, Lyden S, Lee V, Hu M, Adelman M. Venous outcomes at 1 year after using the femoral vein as a conduit for passage of percutaneous femoropopliteal bypass. J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1266-1272.e3. doi: 10.1016/j.jvsv.2020.12.080. Epub 2021 Jan 8.
Results Reference
derived
PubMed Identifier
32276015
Citation
Krievins DK, Halena G, Scheinert D, Savlovskis J, Szopinski P, Kramer A, Ouriel K, Nair K, Holden A, Schmidt A. One-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass. J Vasc Surg. 2020 Nov;72(5):1648-1658.e2. doi: 10.1016/j.jvs.2020.02.043. Epub 2020 Apr 8.
Results Reference
derived

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DETOUR I Clinical Study

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