Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT06002932

Comparison of PROVISIONal 1-stent Strategy with DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.

Led by Saint Vincent's Hospital, Korea · Updated on 2025-02-10

750

Participants Needed

1

Research Sites

277 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

\[The Purpose of the Clinical Study\] The purpose of this randomized comparison study is to compare the 1-stent strategy with a drug-eluting balloon and the 2-stent strategy in patients with non-LM coronary true-bifurcation lesions. \[Hypothesis\] In this study, the researchers intend to verify the hypothesis that the 1-stent strategy with a drug-eluting balloon is non-inferior to the 2-stent strategy in terms of target lesion failures (cardiac death, target vessel MI, or target vessel revascularization).

CONDITIONS

Official Title

Comparison of PROVISIONal 1-stent Strategy with DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 19 years or older
  • Patients with visually confirmed branched vessel diameters between 2.25 and 2.75 mm, where the main vessel diameter is at least 2.5 mm
  • Presence of a true bifurcation lesion classified as Medina (1,1,1), (1,0,1), or (0,1,1)
  • De novo lesion in the involved vessels
  • Patients with stable angina, unstable angina, or non-ST segment elevation myocardial infarction at least 24 hours after last treatment
  • Patients who understand the study groups, risks, and have given informed consent themselves or via legal representatives
Not Eligible

You will not qualify if you...

  • Patients with ST-segment elevation myocardial infarction
  • Patients with left main coronary true-bifurcation lesions
  • Patients deemed unsuitable for 2-stent strategy by the treatment provider due to clinical conditions
  • Patients with contraindications to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
  • Patients experiencing psychogenic shock at admission or severe left ventricular insufficiency (ejection fraction less than 30%)
  • Patients requiring long-term anticoagulant treatment (warfarin or new oral anticoagulants)
  • Patients with active bleeding or high risk of major bleeding, including active peptic ulcers, gastrointestinal lesions, or malignant tumors
  • Patients with history of intracerebral hemorrhage or aneurysm
  • Patients scheduled for surgery requiring antiplatelet therapy within six months
  • Patients with severe liver disease (abdominal effusion), platelet count below 80,000 cells/mm3, or hemoglobin below 10 g/dL
  • Patients at risk of bradycardia without permanent pacemaker and with grade 2 or higher atrioventricular block
  • Pregnant or breastfeeding patients
  • Patients with less than one year life expectancy due to comorbidities
  • Patients enrolled in other randomized clinical studies with unresolved primary endpoints
  • Patients who have not signed informed consent or cannot be followed long-term

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

St. Vincent's Hospital , the Catholic University

Suwon, Gyeonggi-do, South Korea, 16247

Actively Recruiting

Loading map...

Research Team

S

Sung-Ho Her, MD. PhD.

CONTACT

K

Kyusup Lee, MD. PhD.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

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