Last updated on July 2019

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


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02996318

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National Heart Institute

Kuala Lumpur, Malaysia
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University Malaya

Kuala Lumpur, Malaysia
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