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出境医 / 临床实验 / The Future of Revascularization Using a Bioprotec Graft (REVATEC)

The Future of Revascularization Using a Bioprotec Graft (REVATEC)

Study Description
Brief Summary:
The main purpose of this study is the rate assessment of rescued limbs, one year after a BIOPROTEC vascular graft.

Condition or disease Intervention/treatment
Peripheral Artery Disease Procedure: Revascularization using a BIOPROTEC 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
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The Future of the Revascularization Using a Bioprotec Graft
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : September 1, 2023
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The revascularization permeability rate [ 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

  2. The amputation rate [ 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. Infection resistance rate [ 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


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date July 10, 2019
First Posted Date July 15, 2019
Last Update Posted Date January 12, 2021
Actual Study Start Date September 1, 2018
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 12, 2019) 		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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 12, 2019)
  • The revascularization permeability rate [ 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
  • The amputation rate [ 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
  • Infection resistance rate [ 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Future of Revascularization Using a Bioprotec Graft
Official Title The Future of the Revascularization Using a Bioprotec Graft
Brief Summary 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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Grafted patient with a vascular BIOPROTEC graft in case of a Peripheral artery disease.
Condition Peripheral Artery Disease
Intervention Procedure: Revascularization using a BIOPROTEC 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.
Other Name: BIOPROTEC Vascular Graft
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 12, 2019) 		45
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2023
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • ≥ Eighteen years old.
  • Critical ischemia (Phase 4-6 of Rutherford): no saphenous equipment for the vascular reconstruction; at least one leg axis permeable.

Exclusion Criteria:

  • Pregnant woman.
  • Patient with an acute ischemia.
  • Patient with an exceeded ischemia.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Maryline DELATTRE 0033130754131 maryline.delattre@ght-novo.fr
Contact: Véronique DA COSTA 0033130755069 veronique.dacosta@ght-novo.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04018846
Other Study ID Numbers CHRD0518
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier René Dubos
Study Sponsor Centre Hospitalier René Dubos
Collaborators Not Provided
Investigators
Study Director: Jean-Michel DAVAINE, Dr Pitié Salpêtrière Vascular Surgery Service
PRS Account Centre Hospitalier René Dubos
Verification Date November 2020

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