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

April 4, 2024 updated by: Nantes University Hospital

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).

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
228

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49 933
        • Angers University Hospital
      • Besançon, France, 25 000
        • Besançon University Hospital
      • Bordeaux, France, 33000
        • Bordeaux University Hospital - Hôpital Pellegrin
      • Boulogne-Billancourt, France, 92100
        • Ambroise Paré university Hospital
      • Brest, France, 29200
        • Brest University Hospital
      • Clermont-Ferrand, France, 63 003
        • Clermont-Ferrand University Hospital
      • Dijon, France, 21079
        • Dijon University Hospital
      • Lille, France, 59037
        • Lille University Hospital
      • Lyon, France, 69003
        • Lyon University Hospital - Hopital Edouard Herriot
      • Marseille, France, 13005
        • Timone Hospital
      • Nancy, France, 54500
        • Nancy University Hospital
      • Nantes, France, 44800
        • Nantes University Hospital
      • Nice, France, 06000
        • Hôpital Pasteur
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75018
        • Bichat hospital
      • Paris, France, 75014
        • Saint Joseph Hospital
      • Poitiers, France, 86000
        • Poitiers University Hospital
      • Reims, France, 51092
        • Reims University Hospital
      • Saint Etienne, France, 42270
        • Saint Etienne University Hospital
      • Strasbourg, France, 67091
        • Nouvel Hôpital Civil
      • Valenciennes, France, 59322
        • Valenciennes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Revascularization by (Propaten)®
Revascularization by PTFE with heparin bonded luminal surface (Propaten)®
Procedure: revascularization
open revascularization for below-knee popliteal in the absence of an suitable autologous vein with PTFE.
Device: Propaten®
Propaten®
Active Comparator: Revascularization by Crude PTFE
Procedure: revascularization
open revascularization for below-knee popliteal in the absence of an suitable autologous vein with PTFE.
Device: Crude PTFE
Crude PTFE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary patency at 1 year:
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical success defined as a patent bypass without stenosis of the proximal and the distal anastomoses.
Time Frame: 2 years
Stenosis was defined as >30% diameter stenosis noted on intraoperative arteriography.
2 years
Perioperative complications
Time Frame: 2 years
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
2 years
Primary sustained clinical improvement
Time Frame: 1, 12 and 24 months post procedure
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.
1, 12 and 24 months post procedure
Secondary sustained clinical improvement
Time Frame: 1, 12 and 24 months post procedure
defined as primary sustained clinical improvement including the need for repeated graft it self or anastomoses.
1, 12 and 24 months post procedure
Primary patency
Time Frame: 1 and 24 months post procedure
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 and 24 months post procedure
Major adverse cardiovascular events
Time Frame: 1, 12 and 24 months post procedure
defined as MACEs including all cardiac deaths, Q wave infarction, stroke
1, 12 and 24 months post procedure
MALE (Major Adverse Limb Event)-free survival rates in subjects with CLI randomized to Propaten vs. crude ePTFE.
Time Frame: 1, 6, 12 and 24 months
MALE is defined as above-ankle amputation of the index limb or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/ thrombolysis).
1, 6, 12 and 24 months
Limb salvage defined as freedom from above-ankle amputation of the index limb
Time Frame: 1, 12 and 24 months post procedure
1, 12 and 24 months post procedure
Secondary patency
Time Frame: 1, 12 and 24 months post procedure
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.
1, 12 and 24 months post procedure
Assisted patency
Time Frame: 1, 12 and 24 months post procedure
: 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.
1, 12 and 24 months post procedure
Death
Time Frame: 1, 12 and 24 months post procedure
Death (all cause)
1, 12 and 24 months post procedure
Ankle brachial index
Time Frame: 1, 6, 12 and 24 months post procedure
Post-operative assessment (clinical, morphological, hemodynamic criteria)
1, 6, 12 and 24 months post procedure
Quality of life at inclusion, .
Time Frame: 1, 3, 6, 9, 12, 15, 18 and 24 months
assessed according the EQ-5D-3L questionnaire
1, 3, 6, 9, 12, 15, 18 and 24 months
Cost utility analysis (CUA)
Time Frame: 2 years
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.
2 years
cost-effectiveness analysis (CEA)
Time Frame: 2 years
The Measure of outcome for CEA will be the number of Life Years Gained (LYG) at 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
W.L.Gore & Associates

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yann Gouëffic, Pr, Saint Joseph hospital Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC17_0205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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