Recruiting PHASE4 Coronary Arterial Disease (CAD)

Tests treatment safety and results for Coronary Arterial Disease (CAD)

Official title Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques

ClinicalTrials.gov ID: NCT06855537

What this study is testing

What is OMT strategy?

OMT strategy is an investigational medicine, being studied as a potential treatment for coronary arterial disease (cad).

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The aim of this clinical trial is to explore the optimal preventative treatment strategy for non-flow-limiting vulnerable plaques. The main question it aims to answer is: Can interventional therapy further improve the outcome of non-flow-limiting vulnerable plaques on top of optimal pharmacologic therapy?
  • Phase 4: studies an already-approved treatment
  • Time commitment: about 12 months

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 80

You may be able to join if

  • Clinical 1. Males or non-pregnant females aged 18-80 years 2. Clinically diagnosed with acute coronary syndrome (including unstable angina...
  • Successful treatment of all culprit lesions and flow-limited lesions (QFR ≤ 0.8)
  • Reference vessel diameter between 2.5-4.0 mm on imaging assessment
  • Lesion length ≤40 mm
  • At least one significant stenosis (diameter reduction \>50%) demonstrated by angiography, with QFR \>0.80 and OCT-defined TCFA (fibrous cap thickness...

You likely can't join if

  • Clinical Exclusion Criteria
  • Patients with contraindications to dual antiplatelet therapy (DAPT) or planning to discontinue DAPT within one year
  • Patients with other major illnesses and a life expectancy \<2 years
  • Patients scheduled for cardiac surgery or major non-cardiac surgery
  • Women who are breastfeeding, pregnant, or planning pregnancy during the study
  • Patients with severe heart failure (NYHA class III-IV or Killip class III-IV or left ventricular ejection fraction \<35%)
See the full eligibility criteria
Who can join
  • Clinical 1. Males or non-pregnant females aged 18-80 years 2. Clinically diagnosed with acute coronary syndrome (including unstable angina, ST-segment elevation myocardial infarction, and non-ST-segment elevation...
  • Successful treatment of all culprit lesions and flow-limited lesions (QFR ≤ 0.8)
  • Reference vessel diameter between 2.5-4.0 mm on imaging assessment
  • Lesion length ≤40 mm
  • At least one significant stenosis (diameter reduction \>50%) demonstrated by angiography, with QFR \>0.80 and OCT-defined TCFA (fibrous cap thickness \ 90°)
What rules you out
  • Clinical Exclusion Criteria
  • Patients with contraindications to dual antiplatelet therapy (DAPT) or planning to discontinue DAPT within one year
  • Patients with other major illnesses and a life expectancy \<2 years
  • Patients scheduled for cardiac surgery or major non-cardiac surgery
  • Women who are breastfeeding, pregnant, or planning pregnancy during the study
  • Patients with severe heart failure (NYHA class III-IV or Killip class III-IV or left ventricular ejection fraction \<35%)
  • Patients with estimated glomerular filtration rate \<30 mL/(min 1.73 m²)
  • Patients with allergy to contrast agents or DES drugs
  • Patients currently enrolled in other clinical studies Angiographic Exclusion Criteria 1\. Patients for whom CABG is the preferred treatment 2. Target lesion is a previously stented lesion 3. Target lesion is a...

The study team makes the final eligibility decision.

Where it's taking place

  • Beijing, Beijing Municipality, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.