Coronary Artery DiseaseAngionixNCT07869602
Efficacy and Safety of the Angionix Balloon in Patients With Coronary Artery Disease Undergoing PTCA
An observational study of Coronary Artery Disease, run by Yonsei University at 3 sites in South Korea.
Trial summary
A Multi-center, Registry evaluating the efficacy and safety of the use of Angionix Balloon in Patient with Coronary Artery Disease Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Angionix Balloon
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 9 Nov 2026to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites
Kyungpook National University College Hospital
Daegu, Gyeongsangnam-do, 136-705
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Yongcheol Kim
Yongin, Gyeonggi-do, 16995
About this study
Official title: A Multi-center, Registry Evaluating the Efficacy and Safety of the Use of Angionix Balloon in Patient With Coronary Artery Disease
A Multi-center, Registry evaluating the efficacy and safety of the use of Angionix Balloon in Patient with Coronary Artery Disease
Read the detailed description
This study is designed to evaluate the safety and efficacy of the Angionix Balloon-a domestically developed coronary balloon dilatation catheter-when used in percutaneous coronary angioplasty (PTCA) for patients with coronary artery disease.
The main objectives are to assess procedural success rates, vessel expansion success, and the occurrence of major complications during real-world clinical use in lesion preparation and stent post-dilation.
- Conditions
- Coronary Artery Disease
- Being tested
- Angionix Balloon
- Keywords
- coronary artery disease, balloon, Angionix
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Angionix Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the procedure (immediately after balloon dilatation)
Secondary outcomes (2)
Final procedural success
Final procedural success is defined as successful balloon angioplasty (minimum diameter stenosis < 30% + final TIMI flow grade 3 without fatal complications during procedure for DCB/POBA) or successful stent implantation (minimum diameter stenosis < 20% + final TIMI flow grade 3 without fatal complications during procedure).
Measured: At the end of the PTCA procedure
Incidence of fatal complications during procedure
Occurrence of fatal complications during the procedure, defined as: perforation, cardiac tamponade, emergent operation, intraprocedural stent thrombosis, no reflow / acute closure, distal embolization, side branch occlusion, or stent migration.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start9 Nov 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- NOBAMEDI CO., LTD.
- Responsible party
- Principal investigator, Yongcheol Kim, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869602
- Sponsor's protocol ID
- 9-2026-0109
- Acronym
- Angionix
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Registry Evaluating the Efficacy and Safety of the Use of Angionix Balloon in Patient With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07869602
- Acronym / sponsor ID
- Angionix / 9-2026-0109
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, balloon, Angionix
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- NOBAMEDI CO., LTD.
- Study start
- 9 Nov 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Multi-center, Registry evaluating the efficacy and safety of the use of Angionix Balloon in Patient with Coronary Artery Disease
Detailed description
This study is designed to evaluate the safety and efficacy of the Angionix Balloon-a domestically developed coronary balloon dilatation catheter-when used in percutaneous coronary angioplasty (PTCA) for patients with coronary artery disease.
The main objectives are to assess procedural success rates, vessel expansion success, and the occurrence of major complications during real-world clinical use in lesion preparation and stent post-dilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Angionix Registry Cohort | – | Device: Angionix BalloonAdult patients aged 19 years or older with coronary artery disease who require percutaneous transluminal coronary angioplasty (PTCA) using Angionix Balloon or Angionix NC Balloon. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angionix BalloonPercutaneous 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. | Device | Angionix Registry Cohort |
Primary outcome
Successful lesion expansion with Angionix Balloon
Time frame: During the procedure (immediately after balloon dilatation)
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.
2 secondary outcomes
Final procedural success
Time frame: At the end of the PTCA procedure
Incidence of fatal complications during procedure
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Yonsei University at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongcheol Kim, MD.,PhD (821058084029, yongcheol@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful lesion expansion with Angionix Balloon (time frame: During the procedure (immediately after balloon dilatation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.