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

Coronary Artery Disease Clinical Trial

— SCBDNMAL  

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: NCT04017364
• Other study ID #: SI-DN-MALAYSIA
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: April 2021
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 31, 2021
• Est. primary completion date: August 30, 2020
• 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:
• PCB PTCA
Predilatation of coronary de-novo stenosis followed by a PCB
• SCB PTCA
Predilatation of coronary de-novo stenosis followed by a SCB

Locations

Country	Name	City	State
Malaysia	Sabah Heart Centre, Queen Elizabeth Hospital II	Kota Kinabalu
Malaysia	Cardio Vascular Sentral	Kuala Lumpur
Malaysia	National Heart Institute	Kuala Lumpur
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Sarawak Heart Centre	Kuching
Malaysia	Hospital Pulau Pinang	Pulau Pinang

Sponsors (1)

Lead Sponsor	Collaborator
InnoRa GmbH

Country where clinical trial is conducted

Malaysia, 

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;1 — 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	combined endpoint of: < 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE	5 days
Secondary	MACE	combined endpoint of: 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