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DAART vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY LESIONS

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05617053
Enrollment
143
Registered
2022-11-15
Start date
2016-01-01
Completion date
2022-10-01
Last updated
2022-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atheroma, Popliteal Artery Stenosis

Keywords

Popliteal artery, Drug-coated balloon, Supera stent, Directional atherectomy

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.

Interventions

DEVICEDAART
DEVICEATP/Supera stenting

Sponsors

Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

*

Design outcomes

Primary

MeasureTime frameDescription
Primary latency 12-months12 monthsprimary patency at 12-months follow-up, defined as absence of binary restenosis or reocclusion on duplex ultrasound examination without repeat target lesion interventions

Secondary

MeasureTime frameDescription
Mortality12-monthsPatients dead all-cause during follow-up
Amputation rate12-monthsPatients with minor or mayor amputation during follow-up
Clinical status12-monthsRutherford classification clinical scale after 12-month follow-up
Secondary Patency12-monthsSecondary patency was defined as requiring a secondary intervention to restore patency after occlusion of the treated segment
Stent fracture12-monthsStent fracture and implantation defects were assessed by high-resolution radiographic imaging performed on the stents of every limb
Primary-assisted patency12-monthsPrimary 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
ABI measurement12-monthsAnkle/Brachial index measurement.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026