Analyzing factors affecting restenosis after drug-coated balloon angioplasty

A Retrospective Study on the Factors of Drug-coated Balloon Restenosis

This study looks at over 5000 patients who had a special heart procedure to see what factors might affect their recovery and the chances of their arteries narrowing again.

Quick facts

• Study type: Observational
• Enrollment: 5000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Henan Institute of Cardiovascular Epidemiology (other)
• Locations: 1 site (Zhengzhou)
• Trial ID: NCT06620458 on ClinicalTrials.gov

What this trial studies

This observational study retrospectively reviews data from over 5000 patients with de novo large-vessel coronary artery disease who underwent paclitaxel drug-coated balloon angioplasty. It aims to identify potential factors influencing cardiovascular outcomes and restenosis rates by examining baseline characteristics, lesion features, and imaging results. The study will assess cardiovascular adverse events at one year, including cardiovascular death and other significant events, alongside coronary angiographic outcomes. The findings could provide insights into improving treatment strategies for patients undergoing this procedure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with coronary artery disease and scheduled for paclitaxel drug-coated balloon angioplasty.

Not a fit: Patients with known allergies to paclitaxel or those with severe complications or serious diseases that limit life expectancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of factors leading to restenosis, potentially improving patient outcomes after angioplasty.

How similar studies have performed: Other studies have explored similar factors in drug-coated balloon procedures, indicating potential for meaningful insights, though this specific analysis may offer novel perspectives.

Eligibility criteria

Inclusion Criteria:

* Age:

  18 years and older.
* Diagnosis:

Diagnosed with coronary artery disease with native large vessel lesions confirmed by coronary angiography.

* Treatment Plan:

Scheduled to receive paclitaxel drug-coated balloon angioplasty.

* Informed Consent:

Patients have been fully informed about the nature and purpose of the study, and have voluntarily agreed to participate, with signed informed consent.

* Physiological Status:

Cardiac function classified as NYHA I-III.

Exclusion Criteria:

* Allergy History:

Known allergies to paclitaxel or any materials used in angioplasty (e.g., contrast agents).

* Severe Complications:

Uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg).

* Other Medical Conditions:

Active bleeding or clotting disorders.

* Other serious diseases with a life expectancy of less than 1 year (e.g., advanced cancer).
* Pregnancy or Nursing: Women who are currently pregnant or breastfeeding.
* Participation in Other Studies: Currently participating in other clinical trials that might affect the results of this study.
* Psychological or Behavioral Factors: History of psychiatric or behavioral disorders that could interfere with adherence to study protocols, or communication barriers that prevent understanding of study requirements.

Where this trial is running

Zhengzhou

• Fuwai Central China Cardiovascular Hospital — Zhengzhou, China (RECRUITING)

Study contacts

• Study coordinator: Quan Guo, MD

Conditions: Coronary Artery Disease, DCB CHD IVUS OCT