Clinical trial NCT05368129: Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After DES Implantation
Official title: Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After Drug-eluting Stent Implantation: a Prospective, Multicenter, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: BrosMed Medical Co., Ltd
First posted: 2022-05-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Minimal stent area
timeFrame: through PCI procedure completion
Secondary outcomes:
measure: PCI success
timeFrame: up to 7 days
measure: Device success
timeFrame: through PCI procedure completion
Other outcomes:
measure: Death
timeFrame: up to 7 days
measure: Dissection
timeFrame: through PCI procedure completion
measure: Stent thrombosis
timeFrame: Within 24 hours after PCI
measure: Perioperative myocardial infarction
timeFrame: Within 48 hours after PCI
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Shao-Liang Chen, MD, PhD
role: STUDY_CHAIR
References: