Comparing IVUS-guided and angiography-guided PCI in diabetic patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of intravascular imaging-guided percutaneous coronary intervention (PCI) compared to traditional angiography-guided PCI in patients with diabetes mellitus. It aims to determine whether IVUS-guided procedures lead to better clinical outcomes, specifically targeting vessel failure, cardiac death, and myocardial infarction. The study will involve patients aged 18 to 80 who require PCI with drug-eluting stents and will exclude those with severe comorbidities. The findings could provide valuable insights into optimizing PCI techniques for diabetic patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age between 18 \~ 80 years old,
2. Confirmed diabetes mellitus
3. Indications for undergoing percutaneous coronary intervention using a drug-eluting stent (Invasive or quantitative fractional flow reserve (QFR or FFR) \<0.80)
4. Silent angina, stable angina, unstable angina, or Non-ST-elevation myocardial infarction

Exclusion Criteria:

1. Cardiogenic shock
2. Previous coronary artery bypass graft (CABG)
3. Left ventricular ejection fraction \< 30%
4. Requiring oral anticoagulation medications
5. Any planned surgery within 12 months
6. Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2
7. Platelet count \< 100,000 mm3
8. Contraindication to study medications or metal
9. Women of childbearing potential
10. Life expectancy \< 1 year
11. Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)

Where it's running

• Nanjing First Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Jing Kan, MD — Nanjing First Hospital, Nanjing Medical University, and Shan'Xi Provincial People's Hospital, China
• Study coordinator: Shao-Liang C Chen, MD
• Email: chmengx@126.com
• Phone: 13605157029

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.