DAART vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY LESIONS

Popliteal Artery Stenosis Clinical Trial

Official title:

DIRECTIONAL ATHERECTOMY WITH ANTIRESTENOTIC THERAPY vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY ATHEROSCLEROTIC LESIONS: A CASE-MATCH PROPENSITY STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05617053
• Other study ID #: PI 22-2967
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: October 1, 2022

Study information

• Verified date: November 2022
• Source: Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: October 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atheroma
• Plaque, Atherosclerotic
• Popliteal Artery Stenosis

Intervention

Device:
• DAART

• ATP/Supera stenting

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary latency 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	12 months
Secondary	Secondary Patency	Secondary patency was defined as requiring a secondary intervention to restore patency after occlusion of the treated segment	12-months
Secondary	Mortality	Patients dead all-cause during follow-up	12-months
Secondary	Amputation rate	Patients with minor or mayor amputation during follow-up	12-months
Secondary	Clinical status	Rutherford classification clinical scale after 12-month follow-up	12-months
Secondary	ABI measurement	Ankle/Brachial index measurement.	12-months
Secondary	Stent fracture	Stent fracture and implantation defects were assessed by high-resolution radiographic imaging performed on the stents of every limb	12-months
Secondary	Primary-assisted patency	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	12-months