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| Name | Class |
|---|---|
| BrosMed Medical Co., Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POT group | Experimental | A total of 24 patients are assigned to POT group after randomization schedule. |
|
| NCB group | Active Comparator | A total of 24 patients are assigned to NCB group after randomization schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balloon dilation | Procedure | Balloon dilation was performed after DES implantation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Minimal stent area | The change of minimum stent area measured by intravascular ultrasound. | through PCI procedure completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Device success |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Dissection | Vessel dissection was noted during the procedure. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shao-Liang Chen, MD, PhD | Nanjing First Hospital, Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Nanjing | Jiangsu | 210006 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Success of the device (successful balloon expansion) must meet the following conditions:
| through PCI procedure completion |
| through PCI procedure completion |
| Stent thrombosis | Stent thrombosis occurred within 24 hours after PCI. | Within 24 hours after PCI |
| Perioperative myocardial infarction | Perioperative myocardial infarction within 48 hours after PCI. | Within 48 hours after PCI |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |