In-Stent Restenosis or De Novo Coronary Artery LesionsNCT07415902
Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol
An observational study of In-Stent Restenosis or De Novo Coronary Artery Lesions, run by DK Medical Technology (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
This clinical trial adopts a retrospective, multicenter design with data registered and collected via an Electronic Data Capture (EDC) system. A total of 252 eligible subjects will be enrolled in the trial, who are consecutively selected in accordance with the inclusion and exclusion criteria from 2022 to the end of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-Stent Restenosis or De Novo Coronary Artery Lesions
- What is being tested?
- Coronary Artery Drug-Coated Balloon Dilatation Catheter
- Type of treatment
- Medical device
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2026to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will retrospectively enroll all eligible subjects aged 18 years and above with in-stent restenosis or de novo coronary artery lesions.
Who may be able to join
- Age: ≥18 years old, regardless of gender;
- Presence of symptomatic coronary heart disease or objective clinical evidence of myocardial ischemia;
- Treated with DCB for one of the following lesions: in-stent restenosis (any stent type) or de novo lesions with a reference vessel diameter of ≥2.0 mm and ≤2.75 mm.
Who cannot join
- Residual stenosis >30% after pre-treatment with type C or higher dissection;
- A history of cardiogenic shock;
- Severe congestive heart failure or NYHA class IV severe heart failure;
- Pregnant or lactating women;
- Life expectancy ≤24 months (e.g., patients with extensive metastatic malignant tumors).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
min jian tang, +8613525571037
About this study
Official title: A Retrospective, Multicenter, Post-marketing Clinical Study to Evaluate the Long-term Efficacy and Safety of Coronary Artery Drug-Coated Balloon Dilatation Catheter in the Treatment of In-Stent Restenosis or De Novo Coronary Artery Lesions
This clinical trial adopts a retrospective, multicenter design with data registered and collected via an Electronic Data Capture (EDC) system. A total of 252 eligible subjects will be enrolled in the trial, who are consecutively selected in accordance with the inclusion and exclusion criteria from 2022 to the end of 2023 in a retrospective manner. Data collection will be conducted at four time points for all enrolled subjects, including the screening period, 6 months (±30 days) after surgery, 12 months (±30 days) after surgery, and 24 months (±60 days) after surgery. Relevant data of retrospective subjects will be obtained by reviewing medical records.
- Being tested
- Coronary Artery Drug-Coated Balloon Dilatation Catheter
- Keywords
- Coronary Artery Drug-Coated Balloon Dilatation Catheter, In-Stent Restenosis, De Novo Coronary Artery Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Artery Drug-Coated Balloon Dilatation CatheterDevice
subjects who have received coronary artery drug-coated balloon dilatation catheter treatment in the selected centers for a period of time since the product's marketing will be screened one by one in accordance with the inclusion and exclusion criteria. During the process, data collection will be conducted by direct medical history collection or reviewing medical records in the medical record system of each center.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Coronary Artery Drug-Coated Balloon Dilatation Catheter Receives: Device: Coronary Artery Drug-Coated Balloon Dilatation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of Target Lesion Failure (TLF).
The percentage of subjects who experience TLF from the treatment of the target lesion with the investigational device to 24 months after surgery among the total number of subjects. TLF is defined as a composite endpoint of cardiac death, target vessel myocardial infarction (Q-wave or non-Q-wave MI), and clinically driven target lesion revascularization (CD-TLR).
Measured: 24 months
Secondary outcomes (5)
Surgical success rate
The percentage of subjects with successful surgery among the total number of subjects. Surgical success is defined as visual residual stenosis diameter ≤30% at the target lesion after PCI, TIMI flow grade 3 (visual assessment), and no rescue stent implantation required.
Measured: Immediately after the treatment
Incidence of stent thrombosis
The percentage of subjects with all stent thrombosis events meeting the ARC criteria (including definite and probable) from the treatment of the target lesion with the investigational device to 24 months after surgery among the total number of subjects.
Measured: 24 months
Incidence of device-related cardiovascular events (DoCE)
The percentage of subjects with device-related cardiovascular events from the treatment of the target lesion with the investigational device to 24 months after surgery among the total number of subjects. The device-related clinical composite cardiovascular endpoint is defined as cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization.
Measured: 24 months
Incidence of patient-related cardiovascular events (PoCE)
The percentage of subjects with patient-related cardiovascular events from the treatment of the target lesion with the investigational device to 24 months after surgery among the total number of subjects. The patient-related clinical composite cardiovascular endpoint is defined as all-cause death, all myocardial infarctions, and any repeat revascularization.
Measured: 24 months
Device usage
The average number of investigational devices used per lesion and the adjuvant devices used.
Measured: Immediately after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start28 Feb 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-Stent Restenosis or De Novo Coronary Artery LesionsStudies 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
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415902
- Sponsor's protocol ID
- TR-0282
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multicenter, Post-marketing Clinical Study to Evaluate the Long-term Efficacy and Safety of Coronary Artery Drug-Coated Balloon Dilatation Catheter in the Treatment of In-Stent Restenosis or De Novo Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT07415902
- Acronym / sponsor ID
- TR-0282
- Keywords
- Coronary Artery Drug-Coated Balloon Dilatation Catheter, In-Stent Restenosis, De Novo Coronary Artery Lesions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- DK Medical Technology (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Feb 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 clinical trial adopts a retrospective, multicenter design with data registered and collected via an Electronic Data Capture (EDC) system. A total of 252 eligible subjects will be enrolled in the trial, who are consecutively selected in accordance with the inclusion and exclusion criteria from 2022 to the end of 2023 in a retrospective manner. Data collection will be conducted at four time points for all enrolled subjects, including the screening period, 6 months (±30 days) after surgery, 12 months (±30 days) after surgery, and 24 months (±60 days) after surgery. Relevant data of retrospective subjects will be obtained by reviewing medical records.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | – | Device: Coronary Artery Drug-Coated Balloon Dilatation CatheterCoronary Artery Drug-Coated Balloon Dilatation Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will retrospectively enroll all eligible subjects aged 18 years and above with in-stent restenosis or de novo coronary artery lesions.
Key inclusion criteria (3 listed)
- Age: ≥18 years old, regardless of gender;
- Presence of symptomatic coronary heart disease or objective clinical evidence of myocardial ischemia;
- Treated with DCB for one of the following lesions: in-stent restenosis (any stent type) or de novo lesions with a reference vessel diameter of ≥2.0 mm and ≤2.75 mm.
Key exclusion criteria (5 listed)
- Residual stenosis >30% after pre-treatment with type C or higher dissection;
- A history of cardiogenic shock;
- Severe congestive heart failure or NYHA class IV severe heart failure;
- Pregnant or lactating women;
- Life expectancy ≤24 months (e.g., patients with extensive metastatic malignant tumors).
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 |
|---|---|---|
| Coronary Artery Drug-Coated Balloon Dilatation Cathetersubjects who have received coronary artery drug-coated balloon dilatation catheter treatment in the selected centers for a period of time since the product's marketing will be screened one by one in accordance with the inclusion and exclusion criteria. During the process, data collection will be conducted by direct medical history collection or reviewing medical records in the medical record system of each center. | Device | treatment group |
Primary outcome
the incidence of Target Lesion Failure (TLF).
Time frame: 24 months
The percentage of subjects who experience TLF from the treatment of the target lesion with the investigational device to 24 months after surgery among the total number of subjects. TLF is defined as a composite endpoint of cardiac death, target vessel myocardial infarction (Q-wave or non-Q-wave MI), and clinically driven target lesion revascularization (CD-TLR).
5 secondary outcomes
Surgical success rate
Time frame: Immediately after the treatment
Incidence of stent thrombosis
Time frame: 24 months
Incidence of device-related cardiovascular events (DoCE)
Time frame: 24 months
Incidence of patient-related cardiovascular events (PoCE)
Time frame: 24 months
Device usage
Time frame: Immediately after the treatment
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 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for In-Stent Restenosis or De Novo Coronary Artery Lesions
Recruiting
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In-Stent Restenosis or De Novo Coronary Artery Lesions, run by DK Medical Technology (Suzhou) Co., Ltd. at 1 site 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 5 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 jian min tang, professor (+8613525571037, tjmgrx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of Target Lesion Failure (TLF). (time frame: 24 months). 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 17 Feb 2026.