Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After DES Implantation
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: Balloon dilation
- Registration Number
- NCT05368129
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description POT group Balloon dilation A total of 24 patients are assigned to POT group after randomization schedule. NCB group Balloon dilation A total of 24 patients are assigned to NCB group after randomization schedule.
- Primary Outcome Measures
Name Time Method Minimal stent area through PCI procedure completion The change of minimum stent area measured by intravascular ultrasound.
- Secondary Outcome Measures
Name Time Method PCI success up to 7 days Successful PCI was defined as diameter stenosis of the target lesion ≤30%, no intraprocedure death, Q-wave or non-Q-wave myocardial infarction, or emergency coronary artery bypass grafting.
Device success through PCI procedure completion Success of the device (successful balloon expansion) must meet the following conditions:
1. Successfully complete the process of delivery, expansion, retraction and withdrawal;
2. There was no balloon related vascular perforation, C-type or above dissection with limited blood flow, and TIMI grading was not lower than before balloon dilation.
Trial Locations
- Locations (1)
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China