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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05368129
Other study ID # NFH20220425
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 8, 2022
Est. completion date December 30, 2023

Study information

Verified date March 2024
Source Nanjing First Hospital, Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Balloon dilation
Balloon dilation was performed after DES implantation.

Locations

Country Name City State
China Nanjing First Hospital Nanjing Jiangsu

Sponsors (2)

Lead Sponsor Collaborator
Nanjing First Hospital, Nanjing Medical University BrosMed Medical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

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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