NCT07869602

Brief Summary

A Multi-center, Registry evaluating the efficacy and safety of the use of Angionix Balloon in Patient with Coronary Artery Disease

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Nov 2026

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

November 9, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

1.3 years

First QC Date

September 30, 2026

Last Update Submit

October 6, 2026

Conditions

Coronary Artery Disease

Keywords

coronary artery diseaseballoonAngionix

Outcome Measures

Primary Outcomes (1)

  • Successful lesion expansion with Angionix Balloon

    Successful lesion expansion is defined as achievement of less than 50% stenosis of the original vessel diameter in the target stenotic lesion treated with Angionix Balloon.

    During the procedure (immediately after balloon dilatation)

Secondary Outcomes (2)

  • Final procedural success

    At the end of the PTCA procedure

  • Incidence of fatal complications during procedure

    Periprocedural

Study Arms (1)

Angionix Registry Cohort

Adult patients aged 19 years or older with coronary artery disease who require percutaneous transluminal coronary angioplasty (PTCA) using Angionix Balloon or Angionix NC Balloon.

Device: Angionix Balloon

Interventions

Angionix BalloonDEVICE

Percutaneous transluminal coronary angioplasty (PTCA) balloon dilatation catheter (Angionix Balloon and Angionix NC Balloon) used for lesion preparation and post-stent dilation in patients with coronary artery disease. Balloon dilatation is performed at nominal pressure or higher for approximately 5 to 10 seconds according to standard clinical procedure.

Angionix Registry Cohort

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with coronary artery disease who visit participating medical centers and are scheduled to undergo percutaneous transluminal coronary angioplasty (PTCA) using Angionix Balloon or Angionix NC Balloon in routine clinical practice.

You may qualify if:

  • Adult aged 19 years or older at baseline
  • Patients diagnosed with coronary artery disease
  • Patients requiring percutaneous transluminal coronary angioplasty (PTCA) with Angionix Balloon or Angionix NC Balloon
  • Patients who voluntarily agree to participate in this study and sign an informed consent form

You may not qualify if:

  • Patients presenting with cardiogenic shock based on the investigator's clinical judgment
  • Patients with vessel dissection already identified on coronary angiography prior to PTCA procedure based on the investigator's clinical judgment
  • Pregnant or lactating women
  • Patients who have other clinically significant findings that make them unsuitable for study participation based on the investigator's medical judgment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Yongcheol Kim

Yongin, Gyeonggi-do, 16995, South Korea

Location

Kyungpook National University College Hospital

Daegu, Gyeongsangnam-do, 136-705, South Korea

Location

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Yongcheol Kim, MD.,PhD

CONTACT

821058084029yongcheol@yuhs.ac

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (Division of Cardiology)

Study Record Dates

First Submitted

September 30, 2026

First Posted

October 9, 2026

Study Start (Estimated)

November 9, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(3)