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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05368129
Recruitment Status : Recruiting
First Posted : May 10, 2022
Last Update Posted : July 5, 2022
Sponsor:
Collaborator:
BrosMed Medical Co., Ltd
Information provided by (Responsible Party):
Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University

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
Coronary Artery Disease Procedure: Balloon dilation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 8, 2022
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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.




Primary Outcome Measures :
  1. Minimal stent area [ Time Frame: through PCI procedure completion ]
    The change of minimum stent area measured by intravascular ultrasound.


Secondary Outcome Measures :
  1. PCI success [ Time Frame: 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 [ Time Frame: through PCI procedure completion ]

    Success of the device (successful balloon expansion) must meet the following conditions:

    1. Successfully complete the process of delivery, expansion, retraction and withdrawal;
    2. 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 [ Time Frame: 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 [ Time Frame: through PCI procedure completion ]
    Vessel dissection was noted during the procedure.

  3. Stent thrombosis [ Time Frame: Within 24 hours after PCI ]
    Stent thrombosis occurred within 24 hours after PCI.

  4. Perioperative myocardial infarction [ Time Frame: Within 48 hours after PCI ]
    Perioperative myocardial infarction within 48 hours after PCI.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05368129


Contacts
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Contact: Shao-Liang Chen, MD, PhD +86-25-52271351 chmengx@126.com
Contact: Jing Kan, MPH +86-25-52271398 kanjingok@126.com

Locations
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China, Jiangsu
Nanjing First Hospital Recruiting
Nanjing, Jiangsu, China, 210006
Contact: Shaoliang Chen, MD    +86 13605157029    chmengx@126.com   
Principal Investigator: Shaoliang Chen, MD         
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
BrosMed Medical Co., Ltd
Investigators
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Study Chair: Shao-Liang Chen, MD, PhD Nanjing First Hospital, Nanjing Medical University
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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    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases