Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After DES Implantation

The current study is designed as a multicenter, randomized and prospective study aiming to compare the change in minimal stent area (MLA) of POT PTCA balloon dilatation catheter on patients with drug-eluting stent (DES) implantation. Based on the previous studies, the MLA in the proximal and distal 3mm segments was 7.38 mm^2 and 8.08 mm^2 before non-compliant balloon (NCB) dilation, respectively. After NCB dilation, that MSA in the proximal and distal 3mm segments was 7.53mm^2 and 9.55mm^2, respectively. As a result, a total of 48 patients with DES implantation are randomized at a ratio of 1:1 to either POT PTCA balloon dilatation catheter group (POT group) or Quantum Maverick balloon catheter group (NCB group) using a randomization schedule blocked by site.

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;
• Participating in another clinical trial and has not completed the primary endpoint observation of the trial;
• Planned multiple operations, failed to follow the treatment prescribed in the protocol or affected data analysis and interpretation;
• Restenosis disease;
• Target lesions with severe calcification require rotary grinding treatment.