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Ischemia LesionsREPLACENCT03430076

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

A study testing revascularization, Propaten® and Crude PTFE in people with Ischemia Lesions, run by Nantes University Hospital at 21 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemia Lesions
What is being tested?
revascularization, Propaten® and Crude PTFE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
21 sitesFrance
Study dates
13 Feb 2018to 29 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

France21 sites

  • Angers University Hospital

    Angers, 49 933

  • Besançon University Hospital

    Besançon, 25 000

  • Bordeaux University Hospital - Hôpital Pellegrin

    Bordeaux, 33000

  • Ambroise Paré university Hospital

    Boulogne-Billancourt, 92100

  • Brest University Hospital

    Brest, 29200

  • Clermont-Ferrand University Hospital

    Clermont-Ferrand, 63 003

  • Dijon University Hospital

    Dijon, 21079

  • Lille University Hospital

    Lille, 59037

  • Lyon University Hospital - Hopital Edouard Herriot

    Lyon, 69003

  • Timone hospital

    Marseille, 13005

  • Nancy University Hospital

    Nancy, 54500

  • Nantes University Hospital

    Nantes, 44800

  • Hopital Pasteur

    Nice, 06000

  • Saint Joseph Hospital

    Paris, 75014

  • Hôpital Européen Georges Pompidou

    Paris, 75015

  • Bichat Hospital

    Paris, 75018

  • Poitiers University Hospital

    Poitiers, 86000

  • Reims university Hospital

    Reims, 51092

  • Saint Etienne University Hospital

    Saint-Etienne, 42270

  • Nouvel Hopital Civil

    Strasbourg, 67091

  • Valenciennes University Hospital

    Valenciennes, 59322

Other trials in France

About this study

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

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).

Read more

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.

Read the 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.

Being tested
revascularization, Propaten®, Crude PTFE
Keywords
vascular prostheses, heparin, ischemia lesions, vascular, critical limb ischemia lesions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • revascularizationProcedure or surgery

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

  • Propaten®Device

    Propaten®

  • Crude PTFEDevice

    Crude PTFE

Study groups in NCT03430076
Study groupRoleWhat they receive
Revascularization by (Propaten)®ExperimentalRevascularization by PTFE with heparin bonded luminal surface (Propaten)®
Receives: Procedure: revascularization; Device: Propaten®
Revascularization by Crude PTFEActive comparatorNot described
Receives: Procedure: revascularization; Device: Crude PTFE

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (15)

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

    Stenosis was defined as >30% diameter stenosis noted on intraoperative arteriography.

    Measured: 2 years

  2. Perioperative complications

    defined as any general complications or local complications that caused or prolonged hospitalization and/or re-intervention, lymphorrhea of more than 3-days and post-operative paresthesia that required drugs. The general complications included death from any cause, MACE. Local complications included MALE, hematoma, active bleeding, local infection, thrombosis, delayed wound healing and false aneurysm

    Measured: 2 years

  3. Primary sustained clinical improvement

    defined as a wound healing and rest pain resolution for patients in CLI, without the need for repeated graft it self or anastomoses in surviving patients.

    Measured: 1, 12 and 24 months post procedure

  4. Secondary sustained clinical improvement

    defined as primary sustained clinical improvement including the need for repeated graft it self or anastomoses.

    Measured: 1, 12 and 24 months post procedure

  5. Primary patency

    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.

    Measured: 1 and 24 months post procedure

  6. Major adverse cardiovascular events

    defined as MACEs including all cardiac deaths, Q wave infarction, stroke

    Measured: 1, 12 and 24 months post procedure

  7. MALE (Major Adverse Limb Event)-free survival rates in subjects with CLI randomized to Propaten vs. crude ePTFE.

    MALE is defined as above-ankle amputation of the index limb or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/ thrombolysis).

    Measured: 1, 6, 12 and 24 months

  8. Limb salvage defined as freedom from above-ankle amputation of the index limb

    Measured: 1, 12 and 24 months post procedure

  9. Secondary patency

    secondary patency in which graft patency is lost (occlusion) and restored by thrombectomy, thrombolysis, or transluminal angioplasty, and/or any problems with the graft itself or one of its anastomoses require revision or reconstruction. Demonstrably patent graft should be by a duplex ultrasound color-flow scan.

    Measured: 1, 12 and 24 months post procedure

  10. Assisted patency

    : Assisted patency at 1, 12 and 24 months post procedure, in which patency was never lost but maintained by prophylactic intervention. Demonstrably patent graft should be by a duplex ultrasound color-flow scan.

    Measured: 1, 12 and 24 months post procedure

  11. Death

    Death (all cause)

    Measured: 1, 12 and 24 months post procedure

  12. Ankle brachial index

    Post-operative assessment (clinical, morphological, hemodynamic criteria)

    Measured: 1, 6, 12 and 24 months post procedure

  13. Quality of life at inclusion, .

    assessed according the EQ-5D-3L questionnaire

    Measured: 1, 3, 6, 9, 12, 15, 18 and 24 months

  14. Cost utility analysis (CUA)

    In CUA, the outcomes of an intervention are evaluated in terms of Quality-Adjusted Life-Years (QALYs). QALYs are a numerical index that encompasses both the length of life and the health-related quality-of-life.

    Measured: 2 years

  15. cost-effectiveness analysis (CEA)

    The Measure of outcome for CEA will be the number of Life Years Gained (LYG) at 2 years

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2018
  2. Study start13 Feb 2018
  3. Primary completion29 Jan 2024
  4. Study completion29 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03430076
Sponsor's protocol ID
RC17_0205
Acronym
REPLACE
Status last verified
Oct 2026
First submitted
16 Jan 2018
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing revascularization, Propaten® and Crude PTFE in people with Ischemia Lesions, run by Nantes University Hospital at 21 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary patency at 1 year: (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03430076.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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