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

Not Applicable

Completed

• Conditions: DES In-stent Stenosis
• Interventions: Device: Sirolimus coated balloon; Device: Paclitaxel coated balloon (SeQuent Please)

• Registration Number: NCT02996318
• Lead Sponsor: InnoRa GmbH

Brief 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.

Study Timeline

• Study Start: 2015-12-01
• Study First Submitted: 2016-12-09
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-19
• Primary Completion: 2017-08-01
• Study Completion: 2017-12-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 18 years of age
• Clinical evidence of stable or unstable angina (acute coronary syndrome) or a positive functional study
• Patients with ≤ 2 primary drug-eluting stent in-stent restenosis (DES-ISR) lesions (≥ 70% diameter stenosis by visual estimation or ≥ 50% and positive functional study) including margin stenosis with max 5mm distance to the stent.

Exclusion Criteria

• Chronic renal insufficiency with serum creatinine levels > 2.0 mg per deciliter
• Known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or sirolimus, and sensitivity to contrast media not amenable to premedication
• Concomitant medical illness associated with a life-expectancy of less than two year
• Lesion length (ISR) > 35 mm, vessel diameter < 2.5 mm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sirolimus coated Balloon	Sirolimus coated balloon	treatment of coronary DES-ISR with a sirolimus coated balloon
Paclitaxel coated balloon (SeQuent Please)	Paclitaxel coated balloon (SeQuent Please)	treatment of coronary DES-ISR with a paclitaxel coated balloon

Primary Outcome Measures

Name	Time	Method
Late lumen loss	6 months	Difference between minimal lumen diameter at follow-up coronary angiography and baseline after PCI

Secondary Outcome Measures

Name	Time	Method
Procedural Success	24 hours	≤ 30% final stenosis, TIMI III flow, no flow-limiting dissection at the conclusion of the procedure, and the absence of in-hospital (24 hour after treatment) MACE
MACE (Major adverse cardiac events)	12 months	MACE will be defined as the occurrence of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at 6 months and 12 months.

Trial Locations

Locations (5)

Queen Elizabeth Hospital II; 🇲🇾 Kota Kinabalu, Malaysia

Hospital Pulau Pinang; 🇲🇾 Pulau Pinang, Malaysia

Sarawak Genaral Hospital Heart Centre; 🇲🇾 Kuching, Malaysia

National Heart Institute; 🇲🇾 Kuala Lumpur, Malaysia

University Malaya; 🇲🇾 Kuala Lumpur, Malaysia