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

Nanjing Medical University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: Balloon dilation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05368129

NFH20220425

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision of informed consent prior to any study specific procedures;
2. Men and women 18 years and older;
3. Patients with asymptomatic myocardial ischemia, stable or unstable angina, or acute myocardial infarction with symptoms lasting more than 12 hours;
4. The target lesions was de novo lesion;
5. Reference vessel diameter of target lesion is between 2.25-4.0mm, and the lesion length is less than 15mm(visual inspection);
6. Diameter stenosis of target lesion diameter ≥70% or ≥50%(visual) with ischemia evidence;
7. DES was successfully implanted in target lesions;
8. TIMI 3 blood flow of target vessel before post-dilation.

Exclusion criteria

1. Subjects had clinical symptoms and/or ECG changes consistent with ST-elevation myocardial infarction within 12 hours;
2. Allergies to concomitant medications required by the balloon/stent system or protocol used in the study;
3. Cannot tolerate dual antiplatelet therapy;
4. Life expectancy is less than 6 months;
5. Pregnant or lactating women;
6. Participating in another clinical trial and has not completed the primary endpoint observation of the trial;
7. Planned multiple operations, failed to follow the treatment prescribed in the protocol or affected data analysis and interpretation;
8. Restenosis disease;
9. Target lesions with severe calcification require rotary grinding treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

POT group

Experimental group

Description:

A total of 24 patients are assigned to POT group after randomization schedule.

Treatment:

Procedure: Balloon dilation

NCB group

Active Comparator group

Description:

A total of 24 patients are assigned to NCB group after randomization schedule.

Treatment:

Procedure: Balloon dilation