Status:
COMPLETED
Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After DES Implantation
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Collaborating Sponsors:
BrosMed Medical Co., Ltd
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05368129
Start Date
June 8 2022
End Date
December 30 2023
Last Update
March 21 2024
Active Locations (1)
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1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006