Coronary Artery Disease
Conditions
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.
Interventions
PROCEDUREBalloon dilation
Balloon dilation was performed after DES implantation.
Sponsors
BrosMed Medical Co., Ltd
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimal stent area | through PCI procedure completion | The change of minimum stent area measured by intravascular ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Death | up to 7 days | 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 |
| Perioperative myocardial infarction | Within 48 hours after PCI | Perioperative myocardial infarction within 48 hours after PCI. |
| Dissection | through PCI procedure completion | Vessel dissection was noted during the procedure. |
| Stent thrombosis | Within 24 hours after PCI | Stent thrombosis occurred within 24 hours after PCI. |
Countries
China
Outcome results
None listed