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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHenan Institute of Cardiovascular Epidemiology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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)).

Time frame
12 months

Secondary outcomes

1

LLL(late lumen loss)

Detection by QCA technique by subtracting the minimum lumen diameter at review from the minimum lumen diameter in the immediate postoperative period

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.