PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass (PQB4FP1)

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

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: PQ Bypass Guide Wire Delivery System

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PQ Bypass Guide Wire Delivery System; PQ Bypass Guide Wire Delivery System to complete percutaneous Fem-pop bypass

Device: PQ Bypass Guide Wire Delivery System; The PQ Bypass Guide Wire Delivery System is used to bypass lesions in the peripheral vasculature percutaneously. A guidewire is placed from the artery proximal to the lesion to the artery distal to the lesion using the vein as a conduit with the Guidewire Delivery System. Once in place, commercially available stent grafts will be placed to complete the bypass.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary Patency	30 days

Collaborators and Investigators

• Sponsor: Endologix
• Investigators: Principal Investigator: Andrew Holden, MD, Auckland City Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: August 20, 2013
• First Submitted That Met QC Criteria: August 22, 2013
• First Posted (Estimated): August 28, 2013

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: STP 114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No