Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After DES Im… (NCT05368129) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After DES Implantation
China48 participantsStarted 2022-06-08
Plain-language summary
The objective of this randomized control trial is to gain clinical insight on the use of POT PTCA balloon dilatation catheter for the optimal dilation after drug-eluting stent implantation.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provision of informed consent prior to any study specific procedures;
✓. Men and women 18 years and older;
✓. Patients with asymptomatic myocardial ischemia, stable or unstable angina, or acute myocardial infarction with symptoms lasting more than 12 hours;
✓. The target lesions was de novo lesion;
✓. Reference vessel diameter of target lesion is between 2.25-4.0mm, and the lesion length is less than 15mm(visual inspection);
✓. Diameter stenosis of target lesion diameter ≥70% or ≥50%(visual) with ischemia evidence;
✓. DES was successfully implanted in target lesions;
✓. TIMI 3 blood flow of target vessel before post-dilation.
Exclusion criteria
✕. Subjects had clinical symptoms and/or ECG changes consistent with ST-elevation myocardial infarction within 12 hours;
✕. Allergies to concomitant medications required by the balloon/stent system or protocol used in the study;
✕. Cannot tolerate dual antiplatelet therapy;
✕. Life expectancy is less than 6 months;
✕. Pregnant or lactating women;
What they're measuring
1
Minimal stent area
Timeframe: through PCI procedure completion
Trial details
NCT IDNCT05368129
SponsorNanjing First Hospital, Nanjing Medical University