Local Paclitaxel or Balloon Angioplasty Below the Knee (SAMBA)

Prof. Dr. med. Gunnar Tepe

Status: Unknown

Conditions: Restenosis; Occlusion; Stenosis

Treatments: Device: conventional uncoated balloon for BTK endovascular therapy; Device: SequentPlease OTW paclitaxel coated balloon catheter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03149913

BTK 1

Details and patient eligibility

About

Patients with claudication or critical limb ischemia will be treated either with uncoated balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or occluded below the knee arteries

Full description

After successful guide wire passage of the below the knee index lesions the patients will either receive a treatment with a conventional uncoated balloon or a balloon coated with paclitaxel. Only patients who require follow-up angiography after 6 months will be included in this study. The primary endpoint (index vessel occluded or still open) is at 6 months - the patients will be also followed for 24 months for clinical endpoints. In addition an MRI is planned at 12 months.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >18 years of age
• Chronic stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries
• Rutherford 2-5 patients
• Patients with ≤ 2 BTK lesions (≥ 70% diameter stenosis)
• Lesion length limited to 5-25 cm

Exclusion criteria

• Planned or foreseeable amputation
• Previous amputation at the index limb
• Index vessel with no run-off to the foot distal to the index lesion
• Prior treatment of the index lesion with a drug coated balloon
• In-stent restenosis
• Life expectancy <1 year
• Known creatinine >1.4 mg% if patient is not on dialysis
• Acute thrombus in the index limb
• Aneurysm in the index leg
• Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel
• Patients with concomitant medical illnesses that require cytostatic or radiation therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Drug coated balloon

Experimental group

Description:

SeQuentPlease OTW paclitaxel coated balloon catheter

Treatment:

Device: SequentPlease OTW paclitaxel coated balloon catheter

uncoated PTA balloon catheter

Active Comparator group

Description:

Standard of care uncoated BTK balloon catheter

Treatment:

Device: conventional uncoated balloon for BTK endovascular therapy