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

NCT06620458 | Recruiting DMC

• 1 other identifier: HenanICE202403
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analyze potential factors post paclitaxel drug-coated balloon angioplasty in patients with Denovo large vessels disease. It includes imaging endpoints and clinical event endpoints. Over 5000 patients are expected to be enrolled.

Conditions

Coronary Artery Disease

Keywords

DCB CHD IVUS OCT

Outcome Measures

Primary Outcomes (1)

• MACE

  cardiovascular adverse events:defined as death, Myocardial Infarction (MI, Q waves and non-Q waves), emergent cardiac bypass surgery, or any target lesion revascularization (repeat Percutaneous transluminal coronary angioplasty (PTCA) or Coronary artery bypass grafting (CABG)).

  12 months

Secondary Outcomes (1)

• LLL(late lumen loss)

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study targets adults aged 18 and over who have been diagnosed with coronary artery disease featuring native large vessel lesions and are scheduled to undergo paclitaxel drug-coated balloon angioplasty.

You may qualify if:

• Age:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Fuwai Central China Cardiovascular Hospital

Zhengzhou, 450003, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Muwei Li, Ph.D

  Fuwai central China cardiovascular hospotial

  STUDY CHAIR

Central Study Contacts

Quan Guo, MD

CONTACT

+8615670510031; xinyiguoquan@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

CN (1)