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Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated or a Paclitaxel Coated Balloon

Coronary Restenosis Clinical Trial

Official title:
Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated SEQUENT® SCB RAPID EXCHANGE PTCA Balloon Catheter or a Paclitaxel Coated SEQUENT® PLEASE PTCA Balloon Catheter

Clinical Trial Summary

Treatment of coronary in-stent restenosis (ISR) by a sirolimus coated SEQUENT® SCB RAPID EXCHANGE PTCA balloon catheter or a paclitaxel coated SEQUENT® PLEASE PTCA balloon catheter

Clinical Trial Description

Experimental intervention: Predilatation of coronary ISR with POBA followed by a sirolimus coated SeQuent®SCB balloon balloon (sirolimus 4.0 μg/mm²) Control intervention: Predilatation of coronary ISR with POBA followed by a paclitaxel coated SeQuent®Please balloon or SeQuent®Please NEO balloon (paclitaxel 3.0 μg/mm²) Duration of intervention per patient: minutes Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months clinical follow up ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03242096
Study type Interventional
Source InnoRa GmbH
Contact
Status Completed
Phase N/A
Start date July 21, 2017
Completion date January 31, 2021
View Details
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