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

DES In-stent Stenosis Clinical Trial

— FIMLIMUSDCB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996318
• Other study ID #: SI01
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: December 1, 2017

Study information

• Verified date: August 2021
• Source: InnoRa GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• DES In-stent Stenosis

Intervention

Device:
• Paclitaxel coated balloon (SeQuent Please)
Paclitaxel coated balloon (SeQuent Please)
• Sirolimus coated balloon
Sirolimus coated balloon

Locations

Country	Name	City	State
Malaysia	Queen Elizabeth Hospital II	Kota Kinabalu
Malaysia	National Heart Institute	Kuala Lumpur
Malaysia	University Malaya	Kuala Lumpur
Malaysia	Sarawak Genaral Hospital Heart Centre	Kuching
Malaysia	Hospital Pulau Pinang	Pulau Pinang

Sponsors (1)

Lead Sponsor	Collaborator
InnoRa GmbH

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late lumen loss	Difference between minimal lumen diameter at follow-up coronary angiography and baseline after PCI	6 months
Secondary	Procedural Success	= 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	24 hours
Secondary	MACE (Major adverse cardiac events)	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.	12 months