Coronary Artery Disease Clinical Trial
— POT-DESOfficial 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
Verified date | March 2024 |
Source | Nanjing First Hospital, Nanjing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | December 30, 2023 |
Est. primary completion date | April 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Nanjing First Hospital | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Nanjing First Hospital, Nanjing Medical University | BrosMed Medical Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Death | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 days | up to 7 days | |
Other | Dissection | Vessel dissection was noted during the procedure. | through PCI procedure completion | |
Other | Stent thrombosis | Stent thrombosis occurred within 24 hours after PCI. | Within 24 hours after PCI | |
Other | Perioperative myocardial infarction | Perioperative myocardial infarction within 48 hours after PCI. | Within 48 hours after PCI | |
Primary | Minimal stent area | The change of minimum stent area measured by intravascular ultrasound. | through PCI procedure completion | |
Secondary | PCI success | 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. | up to 7 days | |
Secondary | Device success | Success of the device (successful balloon expansion) must meet the following conditions: Successfully complete the process of delivery, expansion, retraction and withdrawal; 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. |
through PCI procedure completion |
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