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Completed

NCT Number: NCT04017364

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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sabah Heart Centre, Queen Elizabeth Hospital II, Kota Kinabalu, Malaysia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCB PTCA

Device

Predilatation of coronary de-novo stenosis followed by a PCB

SCB PTCA

Device

Predilatation of coronary de-novo stenosis followed by a SCB

Primary outcomes

  1. late lumen loss in-segment

    Time frame: 6 months

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

Secondary outcomes

  1. Procedural success

    Time frame: 5 days

    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

  2. MACE

    Time frame: at 6 and at 12 months

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

Sponsors and collaborators

Lead sponsor

InnoRa GmbH

Industry

Registry information

Official study title

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

Acronym: SCBDNMAL

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 12, 2019
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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