Coronary Heart DiseaseNCT05552911
Drug-coated Balloon Therapy for In-stent Restenosis and de Novo Coronary Lesions
An observational study of Coronary Heart Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This was a single-center, prospective, open-label, observational study. Patients with coronary artery disease confirmed by coronary angiography and treated with drug-coated balloon catheter alone for target vessels were enrolled in the Cardiology Department of our hospital in January 2022. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Pretreatment strategies before drug balloon therapy and Different types of in-stent restenosis were treated with drug-coated balloons
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Dec 2023
- 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 diagnosed with coronary heart disease by coronary angiography and treated with DCB alone in the Department of Cardiology of our hospital since January 2022 were included in this study.
Who may be able to join
- Patients aged ≥18 years with coronary heart disease;
- If the target lesion stenosis ≥70% is complicated with angina pectoris or evidence of myocardial ischemia, DCB should be administered;
- Residual lumen diameter stenosis ≤30% after lesion pretreatment and DCB, no vessel dissection, or type A or B dissection, and TIMI blood flow level 3;
- Target lesions were treated with DCB for the first time.
Who cannot join
- Intraoperative implantation of salvage stent in DCB;
- Acute myocardial infarction occurred within 1 week after DCB operation;
- Less than 3 months of dual antiplatelet therapy after DCB operation, or more than 1 month of discontinuation of antiplatelet therapy;
- The position of the stent could not be determined by coronary angiography.
- Desmovascular disease or left main artery disease;
- Atrial fibrillation;
- Patients with severe heart failure, valvular heart disease, renal insufficiency, severe infection and autoimmune disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Chunjian Li, PhD, +86 13701465229, lijay@njmu.edu.cn
Hui Yong, MD, +86 15951263366, yonghuiwanghui@126.com
About this study
Official title: Clinical Prognosis and Influencing Factors of Drug-coated Balloon Therapy in Patients With Coronary In-stent Restenosis and de Novo Coronary Lesions
This was a single-center, prospective, open-label, observational study. Patients with coronary artery disease confirmed by coronary angiography and treated with drug-coated balloon catheter alone for target vessels were enrolled in the Cardiology Department of our hospital in January 2022. The primary endpoint was late lumen loss within 12±3 months after surgery.
- Conditions
- Coronary Heart Disease
- Being tested
- Pretreatment strategies before drug balloon therapy, Different types of in-stent restenosis were treated with drug-coated balloons
- Keywords
- Drug-coated balloon, Percutaneous coronary intervention
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pretreatment strategies before drug balloon therapyProcedure or surgery
Preconditioning strategies for the treatment of in de novo coronary lesions using drug-coated balloons.
Different types of in-stent restenosis were treated with drug-coated balloonsProcedure or surgery
A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.
| Study group | Role | What they receive |
|---|---|---|
| De novo coronary lesions: cutting balloon group | De novo coronary lesions were pretreated with a cutting balloon and then treated with a drug-coated balloon. Receives: Procedure: Pretreatment strategies before drug balloon therapy | |
| De novo coronary lesions: non-cutting balloon group | De novo coronary lesions were pretreated with a non-cutting (Compliance balloon or/and non-compliant balloon) balloon and then treated with a drug-coated balloon. Receives: Procedure: Pretreatment strategies before drug balloon therapy | |
| In-stent restenosis: Type-I | Body stenosis: restenosis of the stent body, not beyond the edge of the stent.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons. Receives: Procedure: Different types of in-stent restenosis were treated with drug-coated balloons | |
| In-stent restenosis: Type-II | Marginal stenosis type: restenosis at the edge of the stent, stenosis ≥50% within 5mm of the stent edge, which can continue into the stent.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons. Receives: Procedure: Different types of in-stent restenosis were treated with drug-coated balloons | |
| In-stent restenosis:Type-III | Diffuse proliferative type: the lesion extends to the whole scaffold body and beyond the edge of both ends.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons. Receives: Procedure: Different types of in-stent restenosis were treated with drug-coated balloons | |
| In-stent restenosis:Type-IV | Complete occlusion type: complete occlusion in the stent.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons. Receives: Procedure: Different types of in-stent restenosis were treated with drug-coated balloons |
What is being measured
The primary outcome is the main question the study is designed to answer.
LLL of 12±3 months after surgery
Late lumen loss of 12±3 months after surgery
Measured: 12±3 months after surgery
Secondary outcomes (1)
MACE event 12 months after surgery
The incidence of MACE events (target vessel revascularization, target vessel myocardial infarction, cardiac death) at 12 months after surgery.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Jan 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjian Li, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552911
- Sponsor's protocol ID
- 19
- Status last verified
- Oct 2022
- First submitted
- 21 Sep 2022
- Last updated
- 26 Oct 2022
- 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 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Prognosis and Influencing Factors of Drug-coated Balloon Therapy in Patients With Coronary In-stent Restenosis and de Novo Coronary Lesions
- ClinicalTrials.gov ID
- NCT05552911
- Acronym / sponsor ID
- 19
- Conditions
- Coronary Heart Disease
- Keywords
- Drug-coated balloon, Percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 23 Sep 2022 (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 was a single-center, prospective, open-label, observational study. Patients with coronary artery disease confirmed by coronary angiography and treated with drug-coated balloon catheter alone for target vessels were enrolled in the Cardiology Department of our hospital in January 2022. The primary endpoint was late lumen loss within 12±3 months after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| De novo coronary lesions: cutting balloon group | – | Procedure: Pretreatment strategies before drug balloon therapyDe novo coronary lesions were pretreated with a cutting balloon and then treated with a drug-coated balloon. |
| De novo coronary lesions: non-cutting balloon group | – | Procedure: Pretreatment strategies before drug balloon therapyDe novo coronary lesions were pretreated with a non-cutting (Compliance balloon or/and non-compliant balloon) balloon and then treated with a drug-coated balloon. |
| In-stent restenosis: Type-I | – | Procedure: Different types of in-stent restenosis were treated with drug-coated balloonsBody stenosis: restenosis of the stent body, not beyond the edge of the stent.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons. |
| In-stent restenosis: Type-II | – | Procedure: Different types of in-stent restenosis were treated with drug-coated balloonsMarginal stenosis type: restenosis at the edge of the stent, stenosis ≥50% within 5mm of the stent edge, which can continue into the stent.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons. |
| In-stent restenosis:Type-III | – | Procedure: Different types of in-stent restenosis were treated with drug-coated balloonsDiffuse proliferative type: the lesion extends to the whole scaffold body and beyond the edge of both ends.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons. |
| In-stent restenosis:Type-IV | – | Procedure: Different types of in-stent restenosis were treated with drug-coated balloonsComplete occlusion type: complete occlusion in the stent.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with coronary heart disease by coronary angiography and treated with DCB alone in the Department of Cardiology of our hospital since January 2022 were included in this study.
Key inclusion criteria (4 listed)
- Patients aged ≥18 years with coronary heart disease;
- If the target lesion stenosis ≥70% is complicated with angina pectoris or evidence of myocardial ischemia, DCB should be administered;
- Residual lumen diameter stenosis ≤30% after lesion pretreatment and DCB, no vessel dissection, or type A or B dissection, and TIMI blood flow level 3;
- Target lesions were treated with DCB for the first time.
Key exclusion criteria (7 listed)
- Intraoperative implantation of salvage stent in DCB;
- Acute myocardial infarction occurred within 1 week after DCB operation;
- Less than 3 months of dual antiplatelet therapy after DCB operation, or more than 1 month of discontinuation of antiplatelet therapy;
- The position of the stent could not be determined by coronary angiography.
- Desmovascular disease or left main artery disease;
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 |
|---|---|---|
| Pretreatment strategies before drug balloon therapyPreconditioning strategies for the treatment of in de novo coronary lesions using drug-coated balloons. | Procedure or surgery | De novo coronary lesions: cutting balloon group, De novo coronary lesions: non-cutting balloon group |
| Different types of in-stent restenosis were treated with drug-coated balloonsA new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon. | Procedure or surgery | In-stent restenosis: Type-I, In-stent restenosis: Type-II, In-stent restenosis:Type-III, In-stent restenosis:Type-IV |
Primary outcome
LLL of 12±3 months after surgery
Time frame: 12±3 months after surgery
Late lumen loss of 12±3 months after surgery
1 secondary outcome
MACE event 12 months after surgery
Time frame: 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- 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. This study is not recruiting at the moment.
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
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 Coronary Heart Disease, run by The First Affiliated Hospital with Nanjing Medical University 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LLL of 12±3 months after surgery (time frame: 12±3 months after surgery). 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 26 Oct 2022.