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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02996318
Study type Interventional
Source University Hospital, Saarland
Contact
Status Recruiting
Phase Phase 2/Phase 3
Start date May 1, 2016
Completion date September 22, 2022