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

Sponsor
Nanjing First Hospital, Nanjing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05368129
Collaborator
BrosMed Medical Co., Ltd (Industry)
48
Enrollment
1
Location
2
Arms
6.7
Anticipated Duration (Months)
7.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Balloon dilation
 N/A

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 mm2 and 8.08 mm2 before non-compliant balloon (NCB) dilation, respectively. After NCB dilation, that MSA in the proximal and distal 3mm segments was 7.53mm2 and 9.55mm2, 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 Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 8, 2022
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Minimal stent area [through PCI procedure completion]

    The change of minimum stent area measured by intravascular ultrasound.

Secondary Outcome Measures

  1. 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.

  2. Device success [through PCI procedure completion]

    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.

Other Outcome Measures

  1. 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

  2. Dissection [through PCI procedure completion]

    Vessel dissection was noted during the procedure.

  3. Stent thrombosis [Within 24 hours after PCI]

    Stent thrombosis occurred within 24 hours after PCI.

  4. Perioperative myocardial infarction [Within 48 hours after PCI]

    Perioperative myocardial infarction within 48 hours after PCI.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nanjing First Hospital Nanjing Jiangsu China 210006

Sponsors and Collaborators

  • Nanjing First Hospital, Nanjing Medical University
  • BrosMed Medical Co., Ltd

Investigators

  • Study Chair: Shao-Liang Chen, MD, PhD, Nanjing First Hospital, Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shaoliang Chen, MD, Vice President of Nanjing First Hospital, Director of Cardiovascular Department, Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT05368129
Other Study ID Numbers:
  • NFH20220425
First Posted:
May 10, 2022
Last Update Posted:
Jul 5, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Coronary Artery Disease

Study Results

No Results Posted as of Jul 5, 2022