NCT01970579

Clinical Trial on Peripheral Arteries Treated With SeQuent® Please P Paclitaxel Coated Balloon Catheter

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: B. Braun Melsungen AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to assess the safety and efficacy of the paclitaxelreleasing balloon catheter SeQuent® Please P to treat de novo and restenotic lesions in the superficial femoral artery and the proximal two segments of the popliteal artery with reference diameters ≥ 4mm \& ≤ 7mm and lesion lengths ≥ 4 cm \& ≤ 27 cm. It is the intention of this trial to treat suitable target lesions with DCB only.

Conditions

• Stenosis
• Restenosis

Interventions

Type	Name	Description
DEVICE	Paclitaxel coated balloon	* Treatment of target lesion with study balloon (coated). Diameter of treatment balloon = RVD * Each study balloon must only be used once (except postdilatation is necessary which may be done with the same balloon used for the initial dilatation) * Treatment balloon must be 20 mm longer than lesion length (to assure balloon overlap of 10 mm proximal and distal to lesion) * If two treatment balloons are necessary overlap between the balloon must be 10 mm * Inflation pressure 7-10 atm * Intraluminal defects or haziness should be treated with additional inflations and/or aggressive anti-platelet agents or bailout stenting
DEVICE	uncoated PTA catheter	* Treatment of target lesion with study balloon (uncoated). Diameter of treatment balloon = RVD * Each study balloon must only be used once (except postdilatation is necessary which may be done with the same balloon used for the initial dilatation) * Treatment balloon must be 20 mm longer than lesion length (to assure balloon overlap of 10 mm proximal and distal to lesion) * If two treatment balloons are necessary overlap between the balloon must be 10 mm * Inflation pressure 7-10 atm * Intraluminal defects or haziness should be treated with additional inflations and/or aggressive anti-platelet agents or bailout stenting.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-12-01
• Completion: 2019-12-01
• First posted: 2013-10-28
• Last updated: 2020-03-30

Locations

7 sites across 1 country: Germany