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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Balloon dilation

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Collaborators: BrosMed Medical Co., Ltd
• Investigators: Study Chair: Shao-Liang Chen, MD, PhD, Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Actual): April 10, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: NFH20220425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No