NCT04899583

Brief Summary

The aim of this randomized controlled trial is to examine the treatment of coronary bifurcation lesion with a sirolimus coated balloon versus a paclitaxel coated balloon. This trial is designed as prospective, multicenter, randomized and open-label.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

November 10, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

November 29, 2023

Status Verified

May 1, 2023

Enrollment Period

3 years

First QC Date

May 17, 2021

Last Update Submit

November 28, 2023

Conditions

Coronary Bifurcation Lesions

Outcome Measures

Primary Outcomes (1)

  • Diameter stenosis rate of bifurcation lesion determinated by Digital Substraction Angiography (DSA) at 9 months post procedure.

    Defined as (1-minimum lumen diameter of target lesion/reference vessel diameter)\*100% at 9 months post procedure.

    9 months post procedure

Secondary Outcomes (9)

  • Rate of device success

    Immediately after procedure

  • Rate of lesion success

    Immediately after procedure

  • Rate of procedure success

    Immediately after procedure

  • Rate of target lesion failure (TLF) or device-related composite endpoints (DoCE）

    30 days, 6 months, 9 months, 12 months post procedure

  • Rate of patient-related composite endpoints (PoCE）

    30 days, 6 months, 9 months, 12 months post procedure

  • +4 more secondary outcomes

Study Arms (2)

Treatment Group

EXPERIMENTAL

a Sirolimus Coated Balloon

Device: Sirolimus Coated Balloon Catheter

Control Group

ACTIVE COMPARATOR

a Paclitaxel Coated Balloon Catheter

Device: a Paclitaxel Coated Balloon Catheter

Interventions

Sirolimus Coated Balloon CatheterDEVICE

a Sirolimus Coated Balloon Catheter designed and produced by Acotec

Treatment Group
a Paclitaxel Coated Balloon CatheterDEVICE

a Paclitaxel Coated Balloon Catheter(trade name:Bingo)

Control Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years old and ≤75 years old
  • Diagnosed as stable or unstable angina pectoris, asymptomatic myocardial ischemia or old myocardial infarction, or recent myocardial infarction in stable stage.
  • Eligible for balloon dilatation or stent implantation.
  • Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed

You may not qualify if:

  • AMI occurred within 7 days before operation
  • The subjects had congestive heart failure or the heart function was classified as NYHA/KillipIV.
  • Left ventricular ejection fraction (LVEF) \< 35%
  • History of heart transplantation
  • The subjects had severe arrhythmias, such as high-risk ventricular extrasystole and / or ventricular tachycardia.
  • The subjects had stroke, gastrointestinal bleeding or active ulcers, or had a high risk of bleeding in the past 6 months.
  • Active bleeding physique or blood coagulation disorder
  • Known renal insufficiency（eGFR\<30ml/min）
  • Contraindicated to anticoagulants or antiplatelet agents
  • Has a history of percutaneous coronary intervention (PCI) within 6 months before enrollment.
  • Has contraindications for coronary artery bypass grafting
  • known to be allergic to aspirin, heparin, contrast agents, paclitaxel and sirolimus
  • Life expectancy less than 12 months, or unable to complete a 12-month follow-up
  • Pregnant or lactating females, or who plan to become pregnant during a follow-up period of 1 year after operation
  • The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Study Officials

  • Ge Junbo

    Shanghai Zhongshan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Hao

CONTACT

021-64041990lu.hao.@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 24, 2021

Study Start

November 10, 2021

Primary Completion

November 1, 2024

Study Completion

November 1, 2025

Last Updated

November 29, 2023

Record last verified: 2023-05

Locations

CN(1)