Local Paclitaxel or Balloon Angioplasty Below the Knee

Not Applicable

• Conditions: Occlusion; Stenosis; Restenosis
• Interventions: Device: SequentPlease OTW paclitaxel coated balloon catheter; Device: conventional uncoated balloon for BTK endovascular therapy

• Registration Number: NCT03149913
• Lead Sponsor: Prof. Dr. med. Gunnar Tepe

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-12-15
• Study First Submitted: 2017-03-30
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-10
• Last Update Submitted: 2017-05-10
• Study First Posted: 2017-05-11
• Last Update Posted: 2017-05-11
• Primary Completion: 2018-12-30
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug coated balloon	SequentPlease OTW paclitaxel coated balloon catheter	SeQuentPlease OTW paclitaxel coated balloon catheter
uncoated PTA balloon catheter	conventional uncoated balloon for BTK endovascular therapy	Standard of care uncoated BTK balloon catheter

Primary Outcome Measures

Name	Time	Method
Occlusion rate of the target lesion at 6 months	6 +/- 1 months	by digital substraction angiogram or MRI

Secondary Outcome Measures

Name	Time	Method
target lesion revascularization	3, 6, 12 and 24 months	repeat intervention

Trial Locations

Locations (7)

Tepe; 🇩🇪 Rosenheim, BW, Germany

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Germany

Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, BW, Germany

LKH-Univ. Klinikum Graz; 🇦🇹 Graz, Austria

Ev.-Luth. Diakonissenanstalt zu Flensburg; 🇩🇪 Flensburg, Germany

Evangelisches Krankenhaus Mülheim a. d. Ruhr; 🇩🇪 Mülheim, Germany

Klinikum Arnsberg; 🇩🇪 Arnsberg, Germany