A Study for Crossability of Spherical Tip Versus Regular Noncompliant Balloon in Tortuous Coronary Artery Postdilatation

NCT05856344 | Completed DMC

• 1 other identifier: [2023]25
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the crossability of novel spherical tip versus regular noncompliant balloon in CHD population with tortuous coronary artery leisions that requiring postdilation after stent implantation. The main question it aims to answer is: •Wether the spherical tip balloon have advantages in terms of crossability compared to regular noncompliant balloons Participants will sign an informed consent form, collaborate with data collection, and accept the intervention measures from corresponding groups. Researchers will compare spherical tip balloon with regular noncompliant balloon to see if there is any difference in crossability.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Spherical Tip; Noncompliant Balloon; Postdilation; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Success passage rate at the first attempt

  The success passage rate of the noncompliant balloon through the tortuous target lesion at the first attempt

  From start to end of surgery

Secondary Outcomes (4)

• The final success passage rate

  From start to end of surgery

• The number of attempts

  From start to end of surgery

• The time required

  From start to end of surgery

• Major adverse cardiac event

  3 months after percutaneous coronary intervention

Study Arms (2)

Spherical tip noncompliant balloon

EXPERIMENTAL

Enrolled patients who were randomly assigned to this group underwent stent postdilation using the spherical tip non compliant balloon(APT Medical Inc，CONQUEROR NC Pro). The selection of balloon size is based on the expected target lesion stent diameter, and the length range is restricted among 8-12mm. It will be defined as balloon passage failure if it fails to pass the target lesion after three attempts. After that, based on the purpose of completing the surgery, alternative options can be selected based on the surgeon's experience, including double-guide wire assistance, 5in6 support, the use of regular noncompliant balloon and so on.

Device: Spherical tip noncompliant balloon

Regular noncompliant balloon

ACTIVE COMPARATOR

Enrolled patients who were randomly assigned to this group underwent stent postdilation using the regular noncompliant balloon(tapered-tip). The selection of balloon size is also based on the expected target lesion stent diameter, and the length range is restricted among 8-12mm. It will be defined as balloon passage failure if it fails to pass the target lesion after three attempts. After that, based on the purpose of completing the surgery, alternative options can be selected based on the surgeon's experience, including tip modification, double-guide wire assistance, 5in6 support, the use of spherical tip non compliant balloon(APT Medical Inc，CONQUEROR NC Pro) and so on.

Device: Regular noncompliant balloon

Interventions

Spherical tip noncompliant balloon DEVICE

The main difference of this experimental balloon is the spherical tip, other parameters are consistent with regular noncompliant balloons.

Spherical tip noncompliant balloon

Regular noncompliant balloon DEVICE

The balloon is designed as tapered-tip.

Regular noncompliant balloon

Eligibility Criteria

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

You may qualify if:

• Over 18 years old, regardless of gender
• Patients with indications for coronary artery stent implantation
• The vascular curvature angle\<120 ° after coronary artery stent implantation
• Noncompliant balloon postdilation is required
• Voluntarily participate and sign an informed consent form

You may not qualify if:

• Pregnant women or patients who are attempting to get pregnant
• Patients participating in clinical trials of other drugs or medical devices
• Patients deemed unsuitable by the researchers to participate in this clinical trial

Sponsors & Collaborators

• First Hospital of China Medical University: lead
• The People's Hospital of Liaoning Province: collaborator

Study Sites (1)

First Hospital of China Medical University

Shenyang, Liaoning, 110001, 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

• Yingxian Sun, Phd

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Cardiology in First Hospital of China Medical University

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 12, 2023
• Study Start: February 20, 2023
• Primary Completion: August 27, 2024
• Study Completion: December 1, 2024
• Last Updated: January 14, 2025

Record last verified: 2025-01

Locations

CN (1)