PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass

NCT ID: NCT01930071

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-06-30

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PQ Bypass Guide Wire Delivery System

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

Group Type: EXPERIMENTAL

PQ Bypass Guide Wire Delivery System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endologix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Holden, MD

Role: PRINCIPAL_INVESTIGATOR

Auckland City Hospital

Locations

Auckland City Hospital

Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

STP 114

Identifier Type: -

Identifier Source: org_study_id