NCT Number: NCT05617053
DAART vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY LESIONS
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.
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Conditions
Age range
18 year–99 year
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
ATP/Supera stenting
DevicePrimary outcomes
-
Primary latency 12-months
Time frame: 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 outcomes
-
Secondary Patency
Time frame: 12-months
Secondary patency was defined as requiring a secondary intervention to restore patency after occlusion of the treated segment
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Mortality
Time frame: 12-months
Patients dead all-cause during follow-up
-
Amputation rate
Time frame: 12-months
Patients with minor or mayor amputation during follow-up
-
Clinical status
Time frame: 12-months
Rutherford classification clinical scale after 12-month follow-up
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ABI measurement
Time frame: 12-months
Ankle/Brachial index measurement.
-
Stent fracture
Time frame: 12-months
Stent fracture and implantation defects were assessed by high-resolution radiographic imaging performed on the stents of every limb
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Primary-assisted patency
Time frame: 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
Sponsors and collaborators
Lead sponsor
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Network
Registry information
Official study title
DIRECTIONAL ATHERECTOMY WITH ANTIRESTENOTIC THERAPY vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY ATHEROSCLEROTIC LESIONS: A CASE-MATCH PROPENSITY STUDY
Important dates
- Study start
- 2016
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Nov 15, 2022
- Registry last updated
- Nov 15, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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