Prevail Drug Balloon Study

Summary

This is an investigator-initiated, prospective, single-centre, non-randomized, all-comers registry that evaluates the safety and efficacy of any Paclitaxel Drug-Coated Balloon (DCB) for the treatment of coronary de novo lesion, in-stent restenosis, and small vessel disease in patients with coronary artery disease in Hong Kong. The recruitment time frame of this study is 1 year from 1st January 2022 to 30th December 2022.

Eligibility

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.

Conditions3

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