PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: PQ Bypass Guide Wire Delivery System

• Registration Number: NCT01930071
• Lead Sponsor: Endologix

Brief Summary

To assess the safety of performing a percutaneous fem-pop bypass using the PQ Bypass Guidewire Delivery System and commercially available stent grafts.

Detailed Description

Multi-center, single-arm first-in-man study utilizing the PQ Bypass Guide Wire Delivery System to access, deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.

Study Timeline

• Study First Submitted: 2013-08-20
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-28
• Study Start: 2013-11
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Willing and able to provide informed consent

• Age 18 or older

• Rutherford Classification of 3-5

• Lesions ≥10cm 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 4.8 - 7.5 mm in diameter

• Orifice and proximal 1cm of SFA is patent

• Patent popliteal artery 3cm proximal to tibial plateau

• At least 1 patent tibial artery to the foot

• Patent femoral vein

Exclusion Criteria

• History of deep vein thrombosis
• Has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated
• Has a known sensitivity or allergy to aspirin, heparin or anti-platelet medications
• Documented in-sensitivity to anti-platelet medication
• Has a known or previous coagulopathy
• Pregnant or lactating
• Untreated flow-limiting aortoiliac occlusive disease
• Has renal failure (GFR < 30mL/min)
• Major distal amputation (above the transmetatarsal) in the study or non-study limb
• Patient has had a procedure on the target limb within 30 days
• Previous bypass surgery on the target limb
• Bypass length required is greater than 35cm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PQ Bypass Guide Wire Delivery System	PQ Bypass Guide Wire Delivery System	PQ Bypass Guide Wire Delivery System to complete percutaneous Fem-pop bypass

Primary Outcome Measures

Name	Time	Method
Primary Patency	30 days

Trial Locations

Locations (1)

Auckland City Hospital; 🇳🇿 Auckland, New Zealand