Clinical trial NCT03430076: Polytetrafluoroethylen (PTFE) Vascular Prostheses With Heparin Bonded Luminal Surfaces vs Crude ePTFE
Official title: Polytetrafluoroethylen (PTFE) Vascular Prostheses With Heparin Bonded Luminal Surfaces vs Crude ePTFE in the Treatment of Critical Limb Ischemia Lesions in the Absence of a Suitable Autologous Vein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemia Lesions
Keywords: vascular prostheses
heparin
ischemia lesions
vascular
critical limb ischemia lesions
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: W.L.Gore & Associates
First posted: 2018-02-12
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Patient inclusion in this study will be proposed 60 to 1-days period preceding the surgical procedure. The patient will be randomized in the crude PTFE or in the Propaten groups. Regarding the intervention, the technique used during the therapeutic procedure shall be left to the operator's discretion, except the type of the graft. Demographic, intraoperative and postoperative data will be collected prospectively. Patient will be assessed and followed up according a current care. The cost difference between both groups will be identified.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Primary patency at 1 year:
timeFrame: 1 year
Secondary outcomes:
measure: Technical success defined as a patent bypass without stenosis of the proximal and the distal anastomoses.
timeFrame: 2 years
measure: Perioperative complications
timeFrame: 2 years
measure: Primary sustained clinical improvement
timeFrame: 1, 12 and 24 months post procedure
measure: Secondary sustained clinical improvement
timeFrame: 1, 12 and 24 months post procedure
measure: Primary patency
timeFrame: 1 and 24 months post procedure
measure: Major adverse cardiovascular events
timeFrame: 1, 12 and 24 months post procedure
measure: MALE (Major Adverse Limb Event)-free survival rates in subjects with CLI randomized to Propaten vs. crude ePTFE.
timeFrame: 1, 6, 12 and 24 months
measure: Limb salvage defined as freedom from above-ankle amputation of the index limb
timeFrame: 1, 12 and 24 months post procedure
measure: Secondary patency
timeFrame: 1, 12 and 24 months post procedure
measure: Assisted patency
timeFrame: 1, 12 and 24 months post procedure
measure: Death
timeFrame: 1, 12 and 24 months post procedure
measure: Ankle brachial index
timeFrame: 1, 6, 12 and 24 months post procedure
measure: Quality of life at inclusion, .
timeFrame: 1, 3, 6, 9, 12, 15, 18 and 24 months
measure: Cost utility analysis (CUA)
timeFrame: 2 years
measure: cost-effectiveness analysis (CEA)
timeFrame: 2 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Besançon
country: France
facility: Besançon University Hospital
city: Bordeaux
country: France
facility: Bordeaux University Hospital - Hôpital Pellegrin
city: Boulogne-Billancourt
country: France
facility: Ambroise Paré university Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
city: Dijon
country: France
facility: Dijon University Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Lyon
country: France
facility: Lyon University Hospital - Hopital Edouard Herriot
city: Marseille
country: France
facility: Timone hospital
city: Nancy
country: France
facility: Nancy University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Nice
country: France
facility: Hopital Pasteur
city: Paris
country: France
facility: Saint Joseph Hospital
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Bichat Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Reims
country: France
facility: Reims university Hospital
city: Saint Etienne
country: France
facility: Saint Etienne University Hospital
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
city: Valenciennes
country: France
facility: Valenciennes University Hospital
Study officials:
affiliation: Saint Joseph Hospital Paris
name: Yann Gouëffic, Pr
role: PRINCIPAL_INVESTIGATOR
References: