Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After DES Implantation

Study Overview
=================
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.

Official 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

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: Balloon dilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POT group<br>A total of 24 patients are assigned to POT group after randomization schedule. | Procedure: Balloon dilation<br>* Balloon dilation was performed after DES implantation.<br>|
| Active Comparator: NCB group<br>A total of 24 patients are assigned to NCB group after randomization schedule. | Procedure: Balloon dilation<br>* Balloon dilation was performed after DES implantation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal stent area | The change of minimum stent area measured by intravascular ultrasound. | through PCI procedure completion | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |