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 Details — Status: Completed

Administrative data

• NCT number: NCT03242096
• Other study ID #: SI-ISR-01
• Status: Completed
• Phase: N/A
• Start date: July 21, 2017
• Est. completion date: January 31, 2021

Study information

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

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 31, 2021
• Est. primary completion date: August 1, 2020
• 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 in-stent restenosis (ISR) lesions (= 70% diameter stenosis by visual estimation or =50% and positive functional study) including margin-stenosis with max 5 mm 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, reference vessel diameter < 2.5 mm

Related Conditions & MeSH terms

• Coronary Restenosis

Intervention

Combination Product:
• Sirolimus coated balloon
Predilatation of coronary ISR with POBA (balloon-to-stent ratio 1:1) followed by a sirolimus coated balloon (SeQuent®SCB balloon with sirolimus 4.0 µg/mm²)
• Paclitaxel coated balloon
Predilatation of coronary ISR with POBA (balloon-to-stent ratio 1:1) followed by a paclitaxel coated balloon (SeQuent®Please balloon or SeQuent®Please NEO balloon with paclitaxel 3.0 µg/mm²) (paclitaxel 3.0 µg/mm²)

Locations

Country	Name	City	State
Germany	Klinik für Innere Medizin und Kardiologie	Dresden
Germany	Clinical and Experimental Interventional Cardiology	Homburg	Saarland
Germany	Deutsches Zentrum für Herz und Kreislauf	Mainz
Germany	Dept. of Internal Medicine II	Ulm
Switzerland	Universitätsspital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
InnoRa GmbH

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. Epub 2006 Nov 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	late lumen loss in-lesion at 6 months	late lumen loss in-lesion at 6 months assessed by blinded QCA	6 months
Secondary	Procedural Success	< 30% final stenosis, TIMI III flow, no flow-limiting dissection, and the absence of in-hospital MACE	during hospital stay of index procedure
Secondary	MACE	cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization	6 and 12 months
Secondary	Individual clinical endpoints	stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, binary restenosis (stenosis = 50% at follow-up angiography)	6 and 12 months