To Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease

Shanghai Bomaian Medical Technology

Status: Not yet enrolling

Conditions: Peripheral Arterial Disease

Treatments: Procedure: Percutaneous selective arteriography of peripheral arteries

Study type: Interventional

Funder types: Industry

Identifiers

NCT05662618

LFBMA-202201

Details and patient eligibility

About

A prospective randomized trial to validate the efficacy and safety of rapamycin coated peripheral balloon catheter in the treatment of femoral popliteal artery disease.

Enrollment: 276 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients with arteriosclerosis obliterans of lower extremities, and Rutherford's rating is 2-5.
• Patients with severe stenosis (≥ 70%) or occlusion of superficial femoral artery and/or proximal popliteal artery (within P1 stage)
• Patients with total length of target lesion ≤ 20cm and length of occluded segment ≤ 15cm (the distance between two segments of lesions less than 2cm is considered as the same lesion)
• Those who agree to participate in this clinical trial and sign the informed consent form Exclusion criteria：
• This operation is planned to intervene patients with bilateral lower limbs.
• Patients whose guide wire fails to pass through the target lesion.
• Patients whose target lesion is in stent restenosis (ISR).
• ≥ 2 lesions need to be treated in the target vessel (if the distance between two lesions is less than 2cm, it is considered as the same lesion).
• Patients with target lesions requiring rotary resection/laser therapy/thrombus aspiration for this treatment.
• Patients with ipsilateral iliac artery inflow tract lesions that cannot be successfully treated (i.e. residual stenosis ≥ 30% after treatment).
• There is less than one unobstructed blood vessel under the knee of the target limb before operation (unobstructed is defined as visual stenosis<50%).
• Residual stenosis ≥ 30% after pre expansion of target lesion or severe (≥ Grade D) flow limiting dissection.
• Patients with obviously abnormal renal function (creatinine > 2.5mg/dL or 220umol/L) or undergoing dialysis.
• Patients with severe liver dysfunction who are judged by the researcher to be unsuitable for surgery.
• Patients with severe coagulation dysfunction or uncontrolled severe infection who are not suitable for surgery.
• Patients who have performed distal amputation (above metatarsal) on the affected or opposite limb in the past.
• Patients who received local or systemic thrombolytic therapy within 48 hours before surgery.
• Patients receiving vascular interventional therapy or surgical treatment on target limb within 30 days before operation.
• Patients known to be allergic to aspirin, clopidogrel, paclitaxel and rapamycin.
• Pregnant or lactating women and patients with family planning during the study
• Patients who are participating in clinical trials of other drugs or medical devices but are not included in the group.
• Patients with life expectancy less than 12 months
• Patients not suitable for this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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276 participants in 2 patient groups

Rapamycin coated peripheral balloon catheter

Experimental group

Description:

Rapamycin coated peripheral balloon catheter of Bomaian Company.

Treatment:

Procedure: Percutaneous selective arteriography of peripheral arteries

Procedure: Percutaneous selective arteriography of peripheral arteries

Drug eluting peripheral balloon catheter

Active Comparator group

Description:

Paclitaxel eluting balloon catheter

Treatment:

Procedure: Percutaneous selective arteriography of peripheral arteries

Procedure: Percutaneous selective arteriography of peripheral arteries