Informations générales (source: ClinicalTrials.gov)
Retrograde Approach in Ambulatory Practice (RAAR)
Observational
Fondation Hôpital Saint-Joseph (Voir sur ClinicalTrials)
juillet 2021
août 2024
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Maxime Raux, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire de Brest - 29200 - Brest - France | Bahaa Nasr, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection