Peripheral Artery DiseaseREVATECNCT04018846
The Future of Revascularization Using a Bioprotec Graft
An observational study of Peripheral Artery Disease, run by Hôpital NOVO at 1 site in France.
Trial summary
The main purpose of this study is the rate assessment of rescued limbs, one year after a BIOPROTEC vascular graft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Revascularization using a BIOPROTEC Graft
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 7 Oct 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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
Study population: Grafted patient with a vascular BIOPROTEC graft in case of a Peripheral artery disease.
Who may be able to join
- ≥ Eighteen years old.
- Critical ischemia (Phase 4-6 of Rutherford): no saphenous equipment for the vascular reconstruction; at least one leg axis permeable.
Who cannot join
- Pregnant woman.
- Patient with an acute ischemia.
- Patient with an exceeded ischemia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Future of the Revascularization Using a Bioprotec Graft
The main purpose of this study is the rate assessment of rescued limbs, one year after a BIOPROTEC vascular graft.
Read the detailed description
The BIOPROTEC grafts are controverted: they are useful in some cases, but they are known as frequently broken or thrombosed. However they are always posed in a complicated situations, in a fragile patients who have ever had many of revascularizations or in an infectious state (which is supportive of the pseudoaneurysm and thrombosis) Despite the frequent use of this graft in France, the results have never been published.
- Conditions
- Peripheral Artery Disease
- Being tested
- Revascularization using a BIOPROTEC Graft
- Keywords
- Peripheral Artery Disease, Revascularization, Graft, Vein, Artery, Limb, Amputation
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revascularization using a BIOPROTEC GraftProcedure or surgery
Also called BIOPROTEC Vascular Graft
It is about a routine care study not changing the usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular Doctor in 1 month, 6 months, 12 months, 18 months and 2 years.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Limb rescue rate one year after a BIOPROTEC graft
Usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular doctor in 1 month, 6 months, 12 months, 18 months and 2 years
Measured: Two years
Secondary outcomes (3)
The revascularization permeability rate
Usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular doctor in 1 month, 6 months, 12 months, 18 months and 2 years
Measured: Two years
The amputation rate
Usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular doctor in 1 month, 6 months, 12 months, 18 months and 2 years
Measured: Two years
Infection resistance rate
Usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular doctor in 1 month, 6 months, 12 months, 18 months and 2 years
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start1 Sep 2018
- Primary completion7 Oct 2021
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel DAVAINE, Dr, Study director, Pitié Salpêtrière Vascular Surgery Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018846
- Sponsor's protocol ID
- CHRD0518
- Acronym
- REVATEC
- Status last verified
- Sep 2023
- First submitted
- 10 Jul 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Future of the Revascularization Using a Bioprotec Graft
- ClinicalTrials.gov ID
- NCT04018846
- Acronym / sponsor ID
- REVATEC / CHRD0518
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral Artery Disease, Revascularization, Graft, Vein, Artery, Limb, Amputation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is the rate assessment of rescued limbs, one year after a BIOPROTEC vascular graft.
Detailed description
The BIOPROTEC grafts are controverted: they are useful in some cases, but they are known as frequently broken or thrombosed. However they are always posed in a complicated situations, in a fragile patients who have ever had many of revascularizations or in an infectious state (which is supportive of the pseudoaneurysm and thrombosis) Despite the frequent use of this graft in France, the results have never been published.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Grafted patient with a vascular BIOPROTEC graft in case of a Peripheral artery disease.
Key inclusion criteria (2 listed)
- ≥ Eighteen years old.
- Critical ischemia (Phase 4-6 of Rutherford): no saphenous equipment for the vascular reconstruction; at least one leg axis permeable.
Key exclusion criteria (3 listed)
- Pregnant woman.
- Patient with an acute ischemia.
- Patient with an exceeded ischemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revascularization using a BIOPROTEC GraftAlso: BIOPROTEC Vascular GraftIt is about a routine care study not changing the usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular Doctor in 1 month, 6 months, 12 months, 18 months and 2 years. | Procedure or surgery | – |
Primary outcome
The Limb rescue rate one year after a BIOPROTEC graft
Time frame: Two years
Usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular doctor in 1 month, 6 months, 12 months, 18 months and 2 years
3 secondary outcomes
The revascularization permeability rate
Time frame: Two years
The amputation rate
Time frame: Two years
Infection resistance rate
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel DAVAINE, Dr study director
Pitié Salpêtrière Vascular Surgery Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by Hôpital NOVO at 1 site 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 2 inclusion and 3 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The Limb rescue rate one year after a BIOPROTEC graft (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.