NCT03149913

Local Paclitaxel or Balloon Angioplasty Below the Knee

Does Local Paclitaxel Improve the Efficacy of Balloon Angioplasty Without Stent Implantation for Treatment of Below the Knee Artery Lesions?

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Prof. Dr. med. Gunnar Tepe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stenosis
• Occlusion
• Restenosis

Interventions

Type	Name	Description
DEVICE	SequentPlease OTW paclitaxel coated balloon catheter	PTA with SequentPlease OTW paclitaxel coated balloon catheter
DEVICE	conventional uncoated balloon for BTK endovascular therapy	PTA with uncoated balloon for BTK endovascular therapy

Timeline

• Start date: 2016-12-15
• Primary completion: 2018-12-30
• Completion: 2020-07-01
• First posted: 2017-05-11
• Last updated: 2017-05-11

Locations

7 sites across 2 countries: Austria, Germany