Retrograde Approach in Ambulatory Practice (RAAR)

August 8, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

Obliterative arterial disease of the lower limbs affects 200 million people worldwide, including approximately 40 million in Europe. This disease is associated with a significant increase in morbidity and mortality.

The most common clinical symptomatology is difficulty walking (intermittent claudication). Less frequent but more severe, critical ischemia includes rest pain requiring analgesics, and trophic disorders (ulcers, gangrene), which may lead to amputation. The Rutherford classification groups the different clinical forms of this pathology. The classic risk factors of cardiovascular pathologies, such as age, smoking, hypertension, diabetes and hypercholesterolemia, are closely linked to Obliterative arterial disease of the lower limbs. Over the past 20 years, the interventional management of this condition has undergone a paradigm shift. The rise of endovascular surgery has broadened the range of therapeutic possibilities, while reducing the impact on patients. Advances in equipment and imaging quality have made it possible to treat increasingly complex lesions, allowing this type of technique to be offered to patients initially treated with conventional surgery (Trans-Atlantic Inter-Society Consensus (TASC) C and D). Unfortunately, for long recanalizations and calcified lesions, the crossing of the lesion and its re-entry into the true arterial lumen is a failure in 25% of cases. It is with this in mind that retrograde puncture and the associated SAFARI (Subintimal Arterial Flossing with Anterograde-retrograde Intervention) technique were developed. In case of failure to cross the lesion by anterograde, intraluminal or subintimal, a retrograde puncture downstream, echo or radio guided, is performed. The vessels most often punctured are the popliteal artery or the leg axes. Recanalization of the lesion is done by retrograde approach. The guidewire introduced distally is recovered in the introducer through which the first recanalization attempt was made. The procedure is then performed in the classical way using the anterograde approach. At the end of the procedure, hemostasis of the puncture site is obtained by prolonged inflation of a balloon or the placement of a covered stent. Initially reserved for critically ischemic patients (Rutherford 4-6), this technique tends to be extended to claudicant patients (Rutherford 2-3). Zhuang et al have recently demonstrated the efficacy and safety of this technique in a large cohort of patients.

In parallel with the evolution of revascularization techniques, the evolution of care pathways has given ambulatory care a prominent place. Since January 2020, in the vascular surgery department of GHPSJ, peripheral angioplasties are mostly performed on an outpatient basis. The patients treated are classified as Rutherford 2 to 5 in most cases. No adverse events related to this management have been reported. To date, no study evaluating the feasibility and safety of retrograde punctures in the outpatient setting has been performed.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

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

Study Contact

  • Name: Maxime Raux, MD
  • Phone Number: +33 144127674
  • Email: mraux@ghpsj.fr

Study Contact Backup

  • Name: Helene BEAUSSIER, PharmD, PhD
  • Phone Number: +33 144127883
  • Email: crc@ghpsj.fr

Study Locations

  • France
      • Brest, France, 29200
        • Recruiting
        • Centre Hospitalier Universitaire de Brest
        • Contact:
        • Principal Investigator:
          • Bahaa Nasr, MD
      • Paris, France, 75014
        • Recruiting
        • Groupe Hospitalier Paris Saint-Joseph
        • Contact:

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

These patients are referred for endovascular revascularization of lower extremity obliterative arterial disease, Rutherford stage 2 to 6, between 01/06/2021 and 01/06/2022.

Description

Inclusion Criteria:

  • Patient with age ≥ 18 years
  • Patient with symptomatic AOMI (Rutherford 2 to 6) with indication for revascularization
  • Patient with ambulatory management
  • Patient whose management requires retrograde arterial puncture
  • Francophone patient
  • Patient who does not object to the use of his/her data for this research

Exclusion Criteria:

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious adverse event
Time Frame: Month 1
This outcome corresponds to the number of the serious adverse event on the operated limb.
Month 1

Collaborators and Investigators

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

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Maxime Raux, MD, Groupe hospitalier Paris saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 21, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

June 29, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • RAAR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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