PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass

NCT01930071 | Completed

• 1 other identifier: STP 114
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Primary Patency

  30 days

Study Arms (1)

PQ Bypass Guide Wire Delivery System

EXPERIMENTAL

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

Device: PQ Bypass Guide Wire Delivery System

Interventions

PQ Bypass Guide Wire Delivery System 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.

PQ Bypass Guide Wire Delivery System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endologix: lead

Study Sites (1)

Auckland City Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Andrew Holden, MD

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 28, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

NZ (1)