Rotational Atherectomy and Drug-Coated Balloon Angioplasty With Embolic Protection for Superficial Femoral Artery Occlusions

N/ANot Yet RecruitingNCT07803718

Sakarya University60 enrolled

Overview

Peripheral artery disease can reduce blood flow to the legs. In some patients, the superficial femoral artery, a major artery in the thigh, is completely blocked over a long segment. This study will evaluate a minimally invasive treatment for these blockages. Approximately 60 adults who require endovascular treatment will undergo placement of a filter beyond the blockage to collect debris. Rotational atherectomy will then be used to remove part of the material causing the blockage, followed by drug-coated balloon angioplasty to widen the artery. A stent may be placed only if needed because of an inadequate treatment result or a procedure-related complication. Participants will be evaluated by clinical examination and duplex ultrasound at 1, 3, 6, and 12 months. The main goal is to determine how often the treated artery remains open at 12 months. The study will also evaluate technical success, the need for repeat treatment, material captured by the filter, and procedure-related blockage of smaller downstream arteries.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Artery Disease Atherectomy in Diseased Lower Extremity Arteries

Interventions

Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon AngioplastyDEVICE

After successful crossing of the superficial femoral artery chronic total occlusion, a distal embolic protection filter will be deployed in the distal superficial femoral or popliteal artery. Rotational atherectomy will be performed to debulk atherosclerotic and thrombotic material, followed by drug-coated balloon angioplasty. Bailout stenting may be performed for flow-limiting dissection, significant residual stenosis, or another inadequate angiographic result.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 years or older Symptomatic peripheral artery disease classified as Rutherford category 2 to 5 Chronic total occlusion of the superficial femoral artery extending from its origin toward Hunter's canal Clinical indication for endovascular treatment At least one patent distal runoff artery Exclusion Criteria: * Acute limb ischemia Severe renal impairment contraindicating iodinated contrast administration Coagulopathy Absence of a patent distal runoff artery

Outcomes

Primary Outcomes

Primary Patency of the Treated Superficial Femoral Artery Segment at 12 Months

The proportion of participants with a patent treated superficial femoral artery segment on duplex ultrasonography, defined as a peak systolic velocity ratio of less than 2.4.

Time frame: 12 months after the index procedure

Secondary Outcomes

Primary Patency of the Treated Superficial Femoral Artery Segment at 1, 3, and 6 Months

The proportion of participants with a patent treated superficial femoral artery segment at each scheduled follow-up, assessed by duplex ultrasonography and defined as a peak systolic velocity ratio of less than 2.4.

Time frame: 1, 3, and 6 months after the index procedure

Target Lesion Revascularization

The proportion of participants requiring repeat endovascular or surgical revascularization of the treated SFA segment.

Time frame: Through 12 months after the index procedure

Periprocedural Distal Embolization

The proportion of participants with clinically evident or angiographically confirmed distal embolization associated with the index procedure.

Time frame: Periprocedural

Macroscopic Material Captured in the Distal Embolic Protection Filter

The proportion of retrieved distal embolic protection filters containing macroscopically visible thrombotic or atheromatous debris.

Time frame: Immediately after the index procedure

Technical Success of the Index Procedure

The proportion of procedures in which the target lesion is successfully crossed and treated with rotational atherectomy and drug-coated balloon angioplasty, with restoration of antegrade flow on final angiography.

Time frame: At the end of the index procedure