Compare Sirolimus Coated Balloon Catheter With Paclitaxel Coated Balloon Catheter in De Novo Coronary Bifurcated Lesions

Last updated: November 8, 2023
Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Thrombosis

Atherosclerosis

Hypercholesterolemia

Treatment

PCI

Clinical Study ID

NCT04918615
D-IC-040
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of Microport sirolimus drug coated balloon catheter for the treatment of coronary bifurcation lesions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or non-pregnant female ages 18-80 years old
  • Participants with myocardial ischemia, stable or unstable angina pectoris, oldmyocardial infarction, or Stabled myocardial infarction (occurred more than 7 daysbefore enrollment, including non-ST elevation and ST elevation myocardial infarction)
  • Participants are are eligible to undergo any type of coronary revascularizationsurgery, such as balloon angioplasty, stenting, and coronary artery bypass grafting (CABG);
  • Participants Can understand the trial's purpose, voluntarily participate andacknowledge all the risks and benefits, providing written informed consent and arewilling to accept invasive radiographic during the follow-up period.
  • Angiography confirmed as De novo bifurcation lesion, the stenosis rate of side branch (diameter) ≥70%
  • Suitable for PCI and the side branch lesions is not expected to stent implantation,and no DCB treatment for the main branch. If a stent is implanted into themain-branch, it's usually necessary to perform a final balloon kissing on the twobranches
  • Up to 2 vessels that need to be treated, total intended treat lesions' amount will notexceed 3
  • At most one primary bifurcation lesion that needs treatment (including Medinaclassification 1.1.1, 1.0.1, 0.1.1), ostium stenosis degree (diameter) ≥70% (visual);
  • Patients are suitable for PCI and side branch is not expected to implant a stent, themain branch will not apply drug coated balloon; the main branch will implant a stent,usually the main branch and side branch will have Kissing Balloon Inflation
  • The side branch is pre-dilated successfully, no C or upper grade dissection, no tearor other complications occurred, residual stenosis ≤50%, TIMI3
  • The reference diameter of the target lesion side branch is 2.0~4.0 mm, the length ofthe lesion in side branch is ≤38 mm, and the length of the lesion in main branch is ≤70 mm

Exclusion

Exclusion Criteria:

  • Any AMI occurred within 1 week before operation
  • Unstable arrhythmias, such as high-risk ventricular premature beats, ventriculartachycardia
  • severe heart failure (above NYHA IV) or Left ventricular ejection fraction (LVEF) <30% (ultrasound or left ventricular angiography)
  • Renal function insufficiency: Serum creatinine >177μmol/L; Or undergoing hemodialysis;
  • definite hemorrhagic tendency, antiplatelet and anticoagulant therapy contraindicationand unable to anticoagulant therapy;
  • PCI planned within 1 year
  • Have a history of peptic ulcer or gastrointestinal hemorrhage in the past 6 months;Have a history of cerebrovascular accidents (stroke) such as cerebral hemorrhage,cerebral infarction in the past 6 months;
  • allergic to contrast agent, paclitaxel, and rapamycin and its derivatives
  • Has been diagnosed as advanced cancer and other serious diseases, lifespan areexpected less than 12 months or hard to complete the 12-month follow up;
  • Patients who are considered to have poor compliance and cannot complete the trial inaccordance with requirements; Or other reasons that considered by the investigator, itbe unsuitable to enroll the participant;
  • Be participating in any other clinical trials, or have participated in clinical trialsof other drugs or medical devices before being selected but have not reached thetimeline of the primary endpoint;
  • Female who are pregnant or breastfeeding (women who may become pregnant must undergo apregnancy test within 7 days before the baseline surgery);Or have fertility plan/cannot have adequate contraception during the study period
  • Three vessel disease and all the vessels need revasculization
  • Left main and its bifurcation lesions;
  • thrombus in the bifurcation lesion, or tortuose lesion that the balloon catheter willnot pass through;
  • Side branch lesion segment of target lesion is a total occlusion lesion
  • side branch is severely calcified, and cannot be pre-dilated or dilated while dokissing balloon inflation;
  • Target lesion (including main branch and branch) is in-stent re-stenosis
  • Dissection above grade C or residual stenosis >50% after pre-dilation of the targetlesion branch vessel disease or double kissing balloon dilation;
  • Two or more non-target lesions that need to be treated, the non-target lesion cannotbe processed before the target lesion or the treatment fails;

Study Design

Total Participants: 236
Treatment Group(s): 1
Primary Treatment: PCI
Phase:
Study Start date:
February 28, 2021
Estimated Completion Date:
December 31, 2024

Study Description

PROMISE-BIF is a prospective, multicenter, randomized controlled, non-inferior clinical trial, which would enroll about 234 participants. All participants will undergo PCI with sirolimus drug coated balloon catheter or paclitaxel drug coated balloon catheter and be followed-up to 24 months.

The Target Lesion defined as the true bifurcation, include the main branch and side branch lesion.

The bifurcation lesions were classified by Medina (1.1.1, 1.0.1, and 0.1.1). The image data will be analyzed and evaluated independently by a third-party imaging laboratory.

Connect with a study center

  • General Hospital of the PLA Northern Theater Command

    Shengyang, Liaoning
    China

    Site Not Available

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