NCT03430076: REPLACE

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

Completed NA Last updated 5 April 2024

What this trial tests

NA trial testing revascularization in Ischemia Lesions in 228 participants. Completed in 29 January 2024.

Timeline

13 February 2018

Primary endpoint
29 January 2024

29 January 2024

Quick facts

Lead sponsor	Nantes University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	228
Start date	13 February 2018
Primary completion	29 January 2024
Estimated completion	29 January 2024
Sites	21 locations across France

Drugs / interventions tested

• revascularization
• Propaten®
• Crude PTFE

Conditions studied

• Ischemia Lesions — all drugs for Ischemia Lesions →

Sponsor

Nantes University Hospital

Who can join

18 and older, any sex, with Ischemia Lesions. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. History, progress and future challenges of artificial blood vessels: a narrative review.
   Hu K, Li Y, Ke Z, Yang H, et al · · 2022 · cited 43× · PMID 35837341 · DOI 10.12336/biomatertransl.2022.01.008