DAART vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY LESIONS

Completed

• Conditions: Popliteal Artery Stenosis; Atheroma
• Interventions: Device: DAART; Device: ATP/Supera stenting

• Registration Number: NCT05617053
• Lead Sponsor: Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-10-01
• Status Verified: 2022-11
• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-08
• Last Update Submitted: 2022-11-08
• Study First Posted: 2022-11-15
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Exclusion Criteria

• Exclusion criteria were patients who could not receive antiplatelet or anticoagulation therapies. Other exclusion criteria were patients with aneurysm of the ipsilateral superficial femoral artery or popliteal artery, acute thrombus, unsalvageable limb, very limited life-expectancy or with doubts in their willingness or capability to allow follow-up examinations.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DAART	DAART	Popliteal artery lesion treated by directional atherectomy with anti-restenotic therapy for the treatment of popliteal atherosclerotic lesions.
ATP/Supera stenting	ATP/Supera stenting	Angioplasty and Supera stent implantation for the treatment of popliteal atherosclerotic lesions.

Primary Outcome Measures

Name	Time	Method
Primary latency 12-months	12 months	primary patency at 12-months follow-up, defined as absence of binary restenosis or reocclusion on duplex ultrasound examination without repeat target lesion interventions

Secondary Outcome Measures

Name	Time	Method
Amputation rate	12-months	Patients with minor or mayor amputation during follow-up
Secondary Patency	12-months	Secondary patency was defined as requiring a secondary intervention to restore patency after occlusion of the treated segment
Stent fracture	12-months	Stent fracture and implantation defects were assessed by high-resolution radiographic imaging performed on the stents of every limb
Clinical status	12-months	Rutherford classification clinical scale after 12-month follow-up
Mortality	12-months	Patients dead all-cause during follow-up
ABI measurement	12-months	Ankle/Brachial index measurement.
Primary-assisted patency	12-months	Primary assisted patency was defined as a patent popliteal segment that underwent further intervention within the inflow, treated vessel segment, or outflow of the treated vessel segment to improve patency