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Trial record 1 of 1 for:    NCT02471638
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PQ Bypass Systems for Femoropopliteal Bypass II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02471638
Recruitment Status : Active, not recruiting
First Posted : June 15, 2015
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
PQ Bypass, Inc.

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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: PQ Bypass System for Femoropopliteal Bypass Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PQ Bypass Systems for Femoropopliteal Bypass II (PQB 4 FP II)
Actual Study Start Date : January 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: Single arm study
PQ Bypass System for Femoropopliteal Bypass to complete percutaneous fem-pop bypass
Device: PQ Bypass System for Femoropopliteal Bypass
To access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.



Primary Outcome Measures :
  1. Primary Performance Endpoint (Rate of primary patency) [ Time Frame: 6 months ]
    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).



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471638


Locations
Chile
Universidad Católica de Chile
Santiago, Chile
Germany
University of Leipzig Medical Centre
Leipzig, Germany, 04103
Italy
Ospedale San Raffaele
Milan, Italy, 20132
Latvia
Stradins University Hospital
Riga, Latvia, LV-1002
New Zealand
Vascular Service
Auckland, New Zealand, 1023
Poland
Gdansk Medical University
Gdańsk, Poland
Poznan University of Medical Sciences
Poznan, Poland, 61-848
Institute of Haematology Medicine Indira Gandhi
Warsaw, Poland
Sponsors and Collaborators
PQ Bypass, Inc.
Investigators
Study Director: James Joye, MD PQ Bypass, Inc.

Responsible Party: PQ Bypass, Inc.
ClinicalTrials.gov Identifier: NCT02471638     History of Changes
Other Study ID Numbers: STP 115
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases