Coronary Artery StenosisNCT07855003
Evaluate the Clinical Efficacy and Safety of Non-Compliant PTCA Balloon Dilatation Catheter
An observational study of Coronary Artery Stenosis and Coronary Artery Disease, run by TEDA International Cardiovascular Hospital at 3 sites in China.
Trial summary
This multi-center, retrospective study included patients diagnosed with coronary artery stenosis treated with NC PTCA balloons between January 2026 and March 2026 at three real-world centers in central China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Stenosis, Coronary Artery Disease, Coronary Balloon
- What is being tested?
- balloon angioplasty
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jul 2026to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary heart disease (CHD) who were treated with at least one NC PTCA balloon dilatation catheter during PCI and had complete case information.
Who may be able to join
- Age ≥18 years.
- Presence of a stenotic lesion in a native coronary artery or bypass graft suitable for percutaneous coronary intervention (PCI).
- The patient voluntarily received NC PTCA treatment (pre-dilation before stent implantation and/or post-dilation after stent implantation).
Who cannot join
- Known contraindications to the investigational device as specified in the product instructions for use.
- Incomplete case information that would affect the evaluation of the primary endpoints.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Lixin County People's Hospital
Bozhou
Dangshan County Traditional Chinese Medicine Hospital
Suzhou
TEDA International Cardiovascular Hospital
Tianjin
About this study
Official title: Evaluate the Clinical Efficacy and Safety of Non-Compliant PTCA Balloon Dilatation Catheter: A Single-arm, Multicenter, Post-market Retrospective Clinical Study
This multi-center, retrospective study included patients diagnosed with coronary artery stenosis treated with NC PTCA balloons between January 2026 and March 2026 at three real-world centers in central China.
Read the detailed description
This study is designed as a retrospective, multicenter, real-world study. A total of 200 patients with coronary heart disease who were consecutively admitted to three centers between January 2026 and March 2026, treated with the NC PTCA balloon catheter, and had complete case information will be enrolled. The primary endpoints are device success rate and procedure success rate, and the secondary endpoints are major adverse cardiovascular events (MACE), target lesion failure (TLF), all-cause death, and myocardial infarction in-hospital.
- Being tested
- balloon angioplasty
- Medical subject headings
- Coronary Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon angioplastyDevice
The balloon catheter expands a stenotic portion of the coronary artery or bypass graft during percutaneous transluminal coronary angioplasty (PTCA). The balloon catheter can be used for post-delivery expansion of balloon expandable stents.
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Success Rate
The balloon successfully reached and crossed the target lesion, was successfully inflated, deflated, and withdrawn back into the guide catheter.
Measured: immediate post-intervention
Procedural Success Rate
Device success, with no device-related adverse events occurring during the inflation process.
Measured: immediate post-intervention
Secondary outcomes (4)
Major Adverse Cardiovascular Events (MACE) during hospitalization
A composite of cardiac death, myocardial infarction, or target lesion revascularisation (TLR)
Measured: during hospitalization, 3-7 days post-procedure
Target Lesion Failure (TLF) during hospitalization
A composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (CD-TLR)
Measured: during hospitalization, 3-7 days post-procedure
All-cause mortality during hospitalization
The proportion of patients who died during the in-hospital until discharge
Measured: during hospitalization, 3-7 days post-procedure
Any myocardial infarction during hospitalization
The proportion of patients who develop any myocardial infarction during the in-hospital until discharge
Measured: during hospitalization, 3-7 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Jul 2026
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery StenosisStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- TEDA International Cardiovascular Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenhua Lin, Principal investigator, TEDA International Cardiovascular Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855003
- Sponsor's protocol ID
- SINOMED-NC-PTCA-202602
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Clinical Efficacy and Safety of Non-Compliant PTCA Balloon Dilatation Catheter: A Single-arm, Multicenter, Post-market Retrospective Clinical Study
- ClinicalTrials.gov ID
- NCT07855003
- Acronym / sponsor ID
- SINOMED-NC-PTCA-202602
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- TEDA International Cardiovascular HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 2 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.
This multi-center, retrospective study included patients diagnosed with coronary artery stenosis treated with NC PTCA balloons between January 2026 and March 2026 at three real-world centers in central China.
Detailed description
This study is designed as a retrospective, multicenter, real-world study. A total of 200 patients with coronary heart disease who were consecutively admitted to three centers between January 2026 and March 2026, treated with the NC PTCA balloon catheter, and had complete case information will be enrolled. The primary endpoints are device success rate and procedure success rate, and the secondary endpoints are major adverse cardiovascular events (MACE), target lesion failure (TLF), all-cause death, and myocardial infarction in-hospital.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary heart disease (CHD) who were treated with at least one NC PTCA balloon dilatation catheter during PCI and had complete case information.
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Presence of a stenotic lesion in a native coronary artery or bypass graft suitable for percutaneous coronary intervention (PCI).
- The patient voluntarily received NC PTCA treatment (pre-dilation before stent implantation and/or post-dilation after stent implantation).
Key exclusion criteria (2 listed)
- Known contraindications to the investigational device as specified in the product instructions for use.
- Incomplete case information that would affect the evaluation of the primary endpoints.
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 |
|---|---|---|
| balloon angioplastyThe balloon catheter expands a stenotic portion of the coronary artery or bypass graft during percutaneous transluminal coronary angioplasty (PTCA). The balloon catheter can be used for post-delivery expansion of balloon expandable stents. | Device | – |
Primary outcome
Device Success Rate
Time frame: immediate post-intervention
The balloon successfully reached and crossed the target lesion, was successfully inflated, deflated, and withdrawn back into the guide catheter.
Procedural Success Rate
Time frame: immediate post-intervention
Device success, with no device-related adverse events occurring during the inflation process.
4 secondary outcomes
Major Adverse Cardiovascular Events (MACE) during hospitalization
Time frame: during hospitalization, 3-7 days post-procedure
Target Lesion Failure (TLF) during hospitalization
Time frame: during hospitalization, 3-7 days post-procedure
All-cause mortality during hospitalization
Time frame: during hospitalization, 3-7 days post-procedure
Any myocardial infarction during hospitalization
Time frame: during hospitalization, 3-7 days post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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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. This study is not recruiting at the moment.
Wenhua Lin principal investigator
TEDA International Cardiovascular Hospital
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 Stenosis and Coronary Artery Disease, run by TEDA International Cardiovascular Hospital at 3 sites in China.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 16 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Success Rate (time frame: immediate post-intervention). The study lists 2 primary outcomes in all. 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 16 Oct 2026.