search
Back to results

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

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Balloon dilation
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanjing First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

POT group

NCB group

Arm Description

A total of 24 patients are assigned to POT group after randomization schedule.

A total of 24 patients are assigned to NCB group after randomization schedule.

Outcomes

Primary Outcome Measures

Minimal stent area
The change of minimum stent area measured by intravascular ultrasound.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 25, 2022
Last Updated
May 14, 2023
Sponsor
Nanjing First Hospital, Nanjing Medical University
Collaborators
BrosMed Medical Co., Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT05368129
Brief Title
Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After DES Implantation
Acronym
POT-DES
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2022 (Actual)
Primary Completion Date
April 10, 2023 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
Collaborators
BrosMed Medical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
POT group
Arm Type
Experimental
Arm Description
A total of 24 patients are assigned to POT group after randomization schedule.
Arm Title
NCB group
Arm Type
Active Comparator
Arm Description
A total of 24 patients are assigned to NCB group after randomization schedule.
Intervention Type
Procedure
Intervention Name(s)
Balloon dilation
Intervention Description
Balloon dilation was performed after DES implantation.
Primary Outcome Measure Information:
Title
Minimal stent area
Description
The change of minimum stent area measured by intravascular ultrasound.
Time Frame
through PCI procedure completion
Secondary Outcome Measure Information:
Title
PCI success
Description
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.
Time Frame
up to 7 days
Title
Device success
Description
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.
Time Frame
through PCI procedure completion
Other Pre-specified Outcome Measures:
Title
Death
Description
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
Time Frame
up to 7 days
Title
Dissection
Description
Vessel dissection was noted during the procedure.
Time Frame
through PCI procedure completion
Title
Stent thrombosis
Description
Stent thrombosis occurred within 24 hours after PCI.
Time Frame
Within 24 hours after PCI
Title
Perioperative myocardial infarction
Description
Perioperative myocardial infarction within 48 hours after PCI.
Time Frame
Within 48 hours after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shao-Liang Chen, MD, PhD
Phone
+86-25-52271351
Email
chmengx@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Kan, MPH
Phone
+86-25-52271398
Email
kanjingok@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-Liang Chen, MD, PhD
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoliang Chen, MD
Phone
+86 13605157029
Email
chmengx@126.com
First Name & Middle Initial & Last Name & Degree
Shaoliang Chen, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs