DAART vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY LESIONS

NCT ID: NCT05617053

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 143 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2022-10-01

Brief Summary

The purpose of this study was to compare the results of directional atherectomy with antirestenotic therapy (DAART technique) and angioplasty/Supera stenting for the treatment of popliteal atherectomy lesions.

Detailed Description

Atherectomy offers a way to improve the chances to avoid stent placement, although it did not show superiority in terms of vessel patency or limb salvage compared with POBA. Nevertheless, atherectomy can modify the plaque morphology and the mechanical properties of the baseline disease, which allows better drug penetration and diffusion into the vessel wall.

Moreover, the combination of directional atherectomy devices and drug coated balloons (directional atherectomy with antirestenotic therapy, DAART), theoretically might further improve the clinical outcomes of drug coated angioplasty. The "leave nothing behind" strategies have gained support among interventionalist. Many studies claim that atherectomy improves results when combined with adjunctive DCB.

The Supera stent, when compared with other self-expanding nitinol stents, has proven to deforms less with knee flexion and exhibits less strain. It mimics the natura structure and movement of the anatomy and optimizes luminal gain maintaining a round open lumen in challenging anatomies, as the popliteal artery. Mechanical scaffolding is often required owing to elastic recoil and flow-limiting dissections in complex popliteal lesions.

The purpose to this study was to retrospectively evaluate the efficacy of both techniques for endovascular treatment of atherosclerotic lesions of the popliteal artery.

Conditions

Popliteal Artery Stenosis; Atheroma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

DAART

Popliteal artery lesion treated by directional atherectomy with anti-restenotic therapy for the treatment of popliteal atherosclerotic lesions.

DAART

Intervention Type: DEVICE

ATP/Supera stenting

Angioplasty and Supera stent implantation for the treatment of popliteal atherosclerotic lesions.

ATP/Supera stenting

Intervention Type: DEVICE

Interventions

DAART

Intervention Type: DEVICE

ATP/Supera stenting

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• patients with lifestyle limiting intermittent claudication ischemic rest pain, ischemic ulcers or gangrene (Rutherford class 3 to 6) who presented atherosclerotic lesions in the popliteal artery undergoing endovascular treatment by DAART of PTA/Supera stenting and at least a 12-months of follow-up

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

NETWORK

Sponsor Role: lead

Responsible Party

Enrique M. San Norberto

MD, PhD, MSc, MPGCert

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PI 22-2967

Identifier Type: -

Identifier Source: org_study_id