Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter

Coronary Artery Disease Clinical Trial

— SCBDENOVO  

Official title:

Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03908450
• Other study ID #: SI-DN-01
• Status: Completed
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: July 31, 2023

Study information

• Verified date: February 2024
• Source: InnoRa GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon

Description:

To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon. Prospective, multicenter, randomized, single-blind, 70 patients. Experimental intervention: Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²). Control intervention: Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²). Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months. clinical follow up Key inclusion criteria: > 18 years of age, Clinical evidence of stable or unstable angina or a positive functional study, Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to <70% diameter stenosis with positive functional test or symptom of ischemia), Successful lesion preparation (no flow-limiting dissection or a residual stenosis > 30%). Key exclusion criteria: Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI), Intolerance and / or allergy to Sirolimus, Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient: iopromide), Patients with an ejection fraction of < 30 %, Reference vessel diameter (RVD) < 2.5 mm, Contraindication for whichever necessary accompanying medication. Primary efficacy endpoint: late lumen loss in-segment at 6 months. Key secondary endpoints: Procedural Success: < 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE. MACE: cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization in-hospital at 6 and at 12 months Individual clinical endpoints at 6 and at 12 months: cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, (stenosis ≥ 50% at follow-up angiography)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical evidence of stable or unstable angina or a positive functional study
• Patients with significant coronary de-novo stenosis (= 70% diameter stenosis or intermediate = 50% to <70% diameter stenosis with positive functional test or symptom of ischemia)
• Successful lesion preparation (no flow-limiting dissection or a residual stenosis > 30%)

Exclusion Criteria:

• Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI)
• Intolerance and / or allergy to Sirolimus
• Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient:

iopromide)

• Patients with an ejection fraction of < 30 %
• Reference vessel diameter (RVD) < 2.5 mm
• Contraindication for whichever necessary accompanying medication

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• PTCA of coronary de novo lesion PCB
PTCA of coronary de novo lesion with drug coated balloon
• PTCA of coronary de novo lesion SCB
PTCA of coronary de novo lesion with drug coated balloon

Locations

Country	Name	City	State
Germany	Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden	Dresden
Germany	Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes	Homburg/Saar	Saarland
Germany	Klinik für Innere Medizin III - Kardiologie Paul Gerhardt Stift	Wittenberg
Switzerland	Universitätsspital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
InnoRa GmbH

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	late lumen loss in-segment	angiographic minimal lumen diameter in-segment at 6 months minus minimal lumen diameter at baseline	6 months
Secondary	Procedural Success	< 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE	in hospital
Secondary	MACE MACE	cardiac death, target vessel myocardial infarction, and TLR target lesion revascularization in-hospital at 6 and at 12 months	at 6 and at 12 months