NCT02996318

Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: InnoRa GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.

Detailed description

The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis. Patient population will consist of male and female adults suffering from coronary drug-eluting stent (DES) restenosis, which is to be treated by a study balloon according to the inclusion and exclusion criteria as defined below. In Late lumen loss lesion (difference between the angiographic in-lesion MLD post procedural and at 6 months follow-up) will be evaluated by quantitative coronary angiography (QCA). The study will be performed as a single-blind, SQP controlled study in 4 - 6 study centers in 50 patients.

Conditions

• DES In-stent Stenosis

Interventions

Type	Name	Description
DEVICE	Paclitaxel coated balloon (SeQuent Please)	Paclitaxel coated balloon (SeQuent Please)
DEVICE	Sirolimus coated balloon	Sirolimus coated balloon

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-08-01
• Completion: 2017-12-01
• First posted: 2016-12-19
• Last updated: 2021-08-27

Locations

5 sites across 1 country: Malaysia