Evaluation of Paclitaxel Drug-Coated Balloon for Treating Coronary Artery Disease

Drug-Coated Balloon for the Treatment of De Novo and Restenotic Coronary Artery Lesion: a Prospective Observational Study

This study is testing if a special balloon coated with a medication can safely help people with coronary artery disease feel better after their treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Chinese University of Hong Kong (Academic / other)
• Locations: 1 site (Shatin)
• Trial ID: NCT05562089 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of Paclitaxel Drug-Coated Balloons (DCB) for treating coronary artery disease, specifically targeting de novo lesions, in-stent restenosis, and small vessel disease. It is a prospective, single-centre, non-randomized registry conducted at the Chinese University of Hong Kong. Patients will undergo a percutaneous intervention with the DCB after meeting specific inclusion criteria, and their clinical outcomes will be assessed at 6 and 12 months post-procedure. The primary endpoints include major adverse cardiac events and procedural success rates.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with significant coronary artery lesions requiring intervention.

Not a fit: Patients with contraindications to the use of drug-coated balloons or those with less than 50% stenosis in target lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with coronary artery disease, potentially reducing the risk of major adverse cardiac events.

How similar studies have performed: Other studies have shown promising results with drug-coated balloons in similar contexts, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Subject age \>18.
2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment.
3. Indication for a percutaneous intervention in native epicardial arteries or bypass graft including patients with stable coronary artery disease and acute coronary syndromes (non- ST-elevated myocardial infarction and ST-elevation myocardial infarction).
4. Target lesion must have a stenosis of \>50% and \<100% angiographically.
5. Target lesion much have an angiographic reference vessel diameter of 2.0-4.0 mm.
6. Successful predilatation of the target lesions as defined by angiographic visual estimate of \<30% residual stenosis without major (defined as \>NHLBI grade B) flow-limiting dissection.
7. Target lesion must have a Thrombolysis in Myocardial Infarction flow \>2 before applying DCB.

Exclusion Criteria:

1. Known history of an allergic reaction or significant sensitivity to paclitaxel or other analogue or derivative.
2. Known history of an allergic reaction or significant sensitivity to urea or its analogue or derivative.
3. Pregnant or breastfeeding woman.
4. Currently participating in an investigational drug or another device study that has not completed the primary end point or that clinically interferes with the current study endpoints.

Where this trial is running

Shatin

• The Chinese University of Hong Kong — Shatin, Hong Kong (Recruiting)

Study contacts

• Principal investigator: Bryan Yan — Chinese University of Hong Kong
• Study coordinator: Daniel Xu

Conditions Myocardial Infarction; Drug-Coated Balloon; De Novo; Restenotic Coronary Artery Lesion; major adverse cardiac event; target-lesion revascularization; Myocardial infraction