NCT04954079

Retrograde Approach in Ambulatory Practice

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Fondation Hôpital Saint-Joseph · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Obliterative Arterial Disease

Timeline

• Start date: 2021-07-21
• Primary completion: 2024-06-01
• Completion: 2024-08-31
• First posted: 2021-07-08
• Last updated: 2023-08-09

Locations

2 sites across 1 country: France