Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT04896177

Sirolimus DEB in Coronary Bifurcation Lesions

Led by Shenzhen Salubris Pharmaceuticals Co., Ltd. · Updated on 2021-05-21

280

Participants Needed

1

Research Sites

287 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the efficacy and safety of sirolimus drug-eluting coronary balloon catheter in treatment of coronary bifurcation lesions. This is a prospective, multicenter, randomized controlled, non-inferior clinical trial, which would enroll 280 participants in total. Paticipants would undergoing PCI with sirolimus DEB or paclitaxel DEB, and be followed-up to 24 months.

CONDITIONS

Official Title

Sirolimus DEB in Coronary Bifurcation Lesions

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 to 85 years
  • Evidence of myocardial ischemia
  • Voluntary participation with signed informed consent
  • Willingness to comply with study protocol and attend follow-ups at 1 month ±7 days, 6 months ±14 days, 9 months ±30 days, 12 months ±30 days, and 24 months ±30 days
  • Angiography confirmed de novo bifurcation lesion with side-branch stenosis diameter of 70% or more
  • Suitable for PCI, side-branch lesions not expected to require stent implantation, and no drug-eluting balloon used for main branch
  • Residual side-branch lesion stenosis of 50% or more after pre-treatment with TIMI flow grade 3
  • Target vessel diameter between 2.0 mm and 4.0 mm
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women, women planning pregnancy within 1 year, or unwilling to use effective contraception
  • Patients in cardiogenic shock
  • Those with bleeding symptoms, active gastrointestinal ulcers, stroke within 6 months, or unable to tolerate dual antiplatelet therapy
  • ST-segment elevation myocardial infarction within 1 week before enrollment
  • Severe congestive heart failure or NYHA class III heart failure
  • Severe valvular heart disease
  • Heart transplant recipients
  • Renal insufficiency with creatinine greater than 3.0 mg/dL or requiring dialysis
  • Life expectancy less than 1 year
  • Contraindications to aspirin, clopidogrel, or ticagrelor
  • Known allergies to paclitaxel, sirolimus, or contrast agents
  • Participation in other drug or device clinical trials without meeting primary endpoints
  • Untreated or unsuccessfully treated non-target lesions before target lesion treatment
  • Intra-stent restenosis
  • High-risk left main disease
  • Other conditions deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200000

Actively Recruiting

Loading map...

Research Team

W

Wei Huang, Dr.

CONTACT

J

Jiatian Cao, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here