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

NCT05368129 | Completed DMC

• 1 other identifier: NFH20220425
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Minimal stent area

  The change of minimum stent area measured by intravascular ultrasound.

  through PCI procedure completion

Secondary Outcomes (2)

• PCI success

  up to 7 days

• Device success

  through PCI procedure completion

Other Outcomes (4)

• Death

  up to 7 days

• Dissection

  through PCI procedure completion

• Stent thrombosis

  Within 24 hours after PCI

Study Arms (2)

POT group

EXPERIMENTAL

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

Procedure: Balloon dilation

NCB group

ACTIVE COMPARATOR

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

Procedure: Balloon dilation

Interventions

Balloon dilation PROCEDURE

Balloon dilation was performed after DES implantation.

NCB group; POT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead
• BrosMed Medical Co., Ltd: collaborator

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Shao-Liang Chen, MD, PhD

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Nanjing First Hospital, Director of Cardiovascular Department

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 10, 2022
• Study Start: June 8, 2022
• Primary Completion: April 10, 2023
• Study Completion: December 30, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)