Polytetrafluoroethylen (PTFE) Vascular Prostheses With Heparin Bonded Luminal Surfaces vs Crude ePTFE

NCT03430076 | Completed DMC

• 1 other identifier: RC17_0205
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 21

Brief Summary

Open repair could be recommended in a first line of treatment to revascularize critical limb ischemia patients or performed in a second line of treatment in case of failure of endovascular repair. A good quality vein is one of the main factors that influence the clinical success of open revascularization for below-knee popliteal. In the absence of an suitable autologous vein, prosthesis such as polytetrafluoroethylen (PTFE) graft could be an option but demonstrated worse clinical and morphological results compared to autologous greater saphenous vein. Consequently, there is still a room for improvement in CLI patients in the absence of an suitable autologous vein in whom endovascular repair failed. Recently, PTFE with heparin-bound to the luminal surface (Hb-PTFE) significantly reduced the overall risk of primary graft failure by 37%, in particular, risk reduction was 50% in femoropopliteal bypass cases in cases with critical ischemia (58% Primary patency for crude ePTFE versus 80% primary patency for PROPATEN at 1 year follow-up) (Lindholt, et. al. 2011). Additionally, a weighted average from the literature suggests a 76% primary patency for below knee bypasses performed with PROPATEN at one year follow-up, whereas a published meta-analysis suggests a 59% primary patency for below knee crude ePTFE at one year follow-up. At two year follow-up using the same approach, the average primary patency for PROPATEN was 67% versus 43% for standard ePTFE. The aim of this study is to assess PTFE with heparin-bound to the luminal surface as an alternative to crude PTFE in absence of good venous conduit in patients with CLI.

Conditions

Ischemia Lesions

Keywords

vascular prostheses; heparin; ischemia lesions; vascular; critical limb ischemia lesions

Outcome Measures

Primary Outcomes (1)

• Primary patency at 1 year:

  It was defined as a patent graft without any intervention to open up or prevent a graft occlusion. Demonstrably patent graft should be by a duplex ultrasound color-flow scan.

  1 year

Secondary Outcomes (15)

• Technical success defined as a patent bypass without stenosis of the proximal and the distal anastomoses.

  2 years

• Perioperative complications

  2 years

• Primary sustained clinical improvement

  1, 12 and 24 months post procedure

• Secondary sustained clinical improvement

  1, 12 and 24 months post procedure

• Primary patency

  1 and 24 months post procedure

Study Arms (2)

Revascularization by (Propaten)®

EXPERIMENTAL

Revascularization by PTFE with heparin bonded luminal surface (Propaten)®

Procedure: revascularization; Device: Propaten®

Revascularization by Crude PTFE

ACTIVE COMPARATOR

Procedure: revascularization; Device: Crude PTFE

Interventions

revascularization PROCEDURE

open revascularization for below-knee popliteal in the absence of an suitable autologous vein with PTFE.

Revascularization by (Propaten)®; Revascularization by Crude PTFE

Propaten® DEVICE

Propaten®

Revascularization by (Propaten)®

Crude PTFE DEVICE

Crude PTFE

Revascularization by Crude PTFE

Eligibility Criteria

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

You may qualify if:

• Patient ≥18 years
• Patient presented critical limb ischemia (Rutherford classification: 4-6)
• Indication of below the knee bypass with an artificial graft
• Absence of an suitable autologous vein
• Patient is affiliated to the Social Security or equivalent system
• Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent form prior to any study related procedure
• Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site

You may not qualify if:

• No atheromatous disease
• Female of child bearing potential
• Patient has a history of coagulopathy or will refuse blood transfusions
• Patient is receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the procedure
• Severe concomitant disease with life expectation \< one year
• Known allergy to heparin
• Indication for ipsilateral major amputation
• Patient is not able to give informed consent
• Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints Note: Trials requiring extended follow-up for products that were investigational, but have become commercially suitable since then, are not considered investigational trials
• In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study

Sponsors & Collaborators

• Nantes University Hospital: lead
• W.L.Gore & Associates: collaborator

Study Sites (21)

Angers University Hospital

Angers, 49 933, France

Location

Besançon University Hospital

Besançon, 25 000, France

Location

Bordeaux University Hospital - Hôpital Pellegrin

Bordeaux, 33000, France

Location

Ambroise Paré university Hospital

Boulogne-Billancourt, 92100, France

Location

Brest University Hospital

Brest, 29200, France

Location

Clermont-Ferrand University Hospital

Clermont-Ferrand, 63 003, France

Location

Dijon University Hospital

Dijon, 21079, France

Location

Lille University Hospital

Lille, 59037, France

Location

Lyon University Hospital - Hopital Edouard Herriot

Lyon, 69003, France

Location

Timone hospital

Marseille, 13005, France

Location

Nancy University Hospital

Nancy, 54500, France

Location

Nantes University Hospital

Nantes, 44800, France

Location

Hopital Pasteur

Nice, 06000, France

Location

Saint Joseph Hospital

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Bichat Hospital

Paris, 75018, France

Location

Poitiers University Hospital

Poitiers, 86000, France

Location

Reims university Hospital

Reims, 51092, France

Location

Saint Etienne University Hospital

Saint-Etienne, 42270, France

Location

Nouvel Hopital Civil

Strasbourg, 67091, France

Location

Valenciennes University Hospital

Valenciennes, 59322, France

Location

Study Officials

• Yann Gouëffic, Pr

  Saint Joseph Hospital Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: February 12, 2018
• Study Start: February 13, 2018
• Primary Completion: January 29, 2024
• Study Completion: January 29, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (21)