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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

PCB PTCA

SCB PTCA

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring drug coated balloon, Paclitaxel, sirolimus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sabah Heart Centre, Queen Elizabeth Hospital II
National Heart Institute
Cardio Vascular Sentral
University Malaya Medical Centre
Sarawak Heart Centre
Hospital Pulau Pinang

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PTCA of coronary de novo lesion PCB

PTCA of coronary de novo lesion SCB

Arm Description

Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²)

Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²)

Outcomes

Primary Outcome Measures

late lumen loss in-segment

angiographic minimal lumen diameter in-segment at 6 months minus minimal lumen diameter at baseline

Secondary Outcome Measures

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

MACE

combined endpoint of: cardiac death, target vessel myocardial infarction, and TLR target lesion revascularization in-hospital at 6 and at 12 months

Full Information

NCT ID

NCT04017364

First Posted

July 3, 2019

Last Updated

August 24, 2021

Sponsor

InnoRa GmbH

1. Study Identification

Unique Protocol Identification Number

NCT04017364

Brief Title

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

Acronym

SCBDNMAL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

August 30, 2020 (Actual)

Study Completion Date

January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InnoRa GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

drug coated balloon, Paclitaxel, sirolimus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PTCA of coronary de novo lesion PCB

Arm Type

Active Comparator

Arm Description

Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²)

Arm Title

PTCA of coronary de novo lesion SCB

Arm Type

Experimental

Arm Description

Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²)

Intervention Type

Device

Intervention Name(s)

PCB PTCA

Intervention Description

Predilatation of coronary de-novo stenosis followed by a PCB

Intervention Type

Device

Intervention Name(s)

SCB PTCA

Intervention Description

Predilatation of coronary de-novo stenosis followed by a SCB

Primary Outcome Measure Information:

Title

late lumen loss in-segment

Description

angiographic minimal lumen diameter in-segment at 6 months minus minimal lumen diameter at baseline

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Procedural success

Description

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

Time Frame

5 days

Title

MACE

Description

combined endpoint of: cardiac death, target vessel myocardial infarction, and TLR target lesion revascularization in-hospital at 6 and at 12 months

Time Frame

at 6 and at 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Sabah Heart Centre, Queen Elizabeth Hospital II

City

Kota Kinabalu

ZIP/Postal Code

88300

Country

Malaysia

Facility Name

National Heart Institute

City

Kuala Lumpur

ZIP/Postal Code

50400

Country

Malaysia

Facility Name

Cardio Vascular Sentral

City

Kuala Lumpur

ZIP/Postal Code

50470

Country

Malaysia

Facility Name

University Malaya Medical Centre

City

Kuala Lumpur

ZIP/Postal Code

50603

Country

Malaysia

Facility Name

Sarawak Heart Centre

City

Kuching

ZIP/Postal Code

94300

Country

Malaysia

Facility Name

Hospital Pulau Pinang

City

Pulau Pinang

ZIP/Postal Code

10990

Country

Malaysia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30898253

Citation

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.

Results Reference

result

PubMed Identifier

35305906

Citation

Ahmad WAW, Nuruddin AA, Abdul Kader MASK, Ong TK, Liew HB, Ali RM, Mahmood Zuhdi AS, Ismail MD, Yusof AKM, Schwenke C, Kutschera M, Scheller B. Treatment of Coronary De Novo Lesions by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2022 Apr 11;15(7):770-779. doi: 10.1016/j.jcin.2022.01.012. Epub 2022 Mar 16.

Results Reference

derived

Learn more about this trial

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

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