Comparison between the long term outcome of lower limb peripheral vascular disease recanalization by atherectomy with drug coated balloon versus atherectomy with stenting

Comparison of the efficacy, safety & patency of combined Directional Atherectomy with Drug-Coated Balloon Angioplasty versus combined Directional Atherectomy with Vascular mimetic Stent placement for the treatment of femoropopliteal atherosclerotic Peripheral Vascular Disease- A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078769

Enrollment

Registered

2024-12-30

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: I702- Atherosclerosis of native arteriesof the extremities

Interventions

Intervention1: DIRECTIONAL ATHERECTOMY WITH DRUG COATED BALLOON ANGIOPLASTY: Endovascular Directional Atherectomy of the lesion will be performed with a 6F Directional Atherectomy System followed by D

Eligibility

Inclusion criteria

Inclusion criteria: Patients with symptomatic chronic lower limb ischemia (Rutherford category 2 to 6) with lifestyle-limiting symptoms such as claudication pain, ischemic rest pain, ischemic ulceration, or gangrene. Imaging (CT / MR angiography) evidence of =70% stenosis, or occlusion of the superficial femoral (SFA) or popliteal artery (PA). Preserved distal perfusion of foot via at least one below knee vessel or collaterals

Exclusion criteria

Exclusion criteria: Clinical or imaging (Duplex ultrasound/CT/MR/DSA angiography) evidence of acute limb ischemia. Previous history of endovascular intervention or bypass surgery of the target limb. Contraindication to antiplatelet therapy, anticoagulants, or any other medication that is planned to be administered. Known hypersensitivity to treatment device material or iodinated contrast agents, that cannot be sufficiently pre-treated. End-stage renal disease.

Design outcomes

Secondary

Measure	Time frame
Complication rateTimepoint: One day, Six months, One year	—

Primary

Measure	Time frame
Technical success, Net luminal gain, Primary patency rateTimepoint: One day, Six months, One year	—

Countries

India

Contacts

Public ContactSatyam Barchha

JAWAHARLAL NEHRU MEDICAL COLLEGE, KLES UNIVERSITY

navinmulimani@gmail.com9409208193

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026