Drug-coated Balloon Therapy for In-stent Restenosis and de Novo Coronary Lesions
NCT ID: NCT05552911
Last Updated: 2022-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2022-01-01
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Pretreatment strategies before drug balloon therapy
Preconditioning strategies for the treatment of in de novo coronary lesions using drug-coated balloons.
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.
Pretreatment strategies before drug balloon therapy
Preconditioning strategies for the treatment of in de novo coronary lesions using drug-coated balloons.
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.
Different types of in-stent restenosis were treated with drug-coated balloons
A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.
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.
Different types of in-stent restenosis were treated with drug-coated balloons
A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.
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.
Different types of in-stent restenosis were treated with drug-coated balloons
A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.
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.
Different types of in-stent restenosis were treated with drug-coated balloons
A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.
Interventions
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Pretreatment strategies before drug balloon therapy
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 balloons
A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.
Eligibility Criteria
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Inclusion Criteria
2. If the target lesion stenosis ≥70% is complicated with angina pectoris or evidence of myocardial ischemia, DCB should be administered;
3. 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;
4. Target lesions were treated with DCB for the first time.
Exclusion Criteria
2. Acute myocardial infarction occurred within 1 week after DCB operation;
3. Less than 3 months of dual antiplatelet therapy after DCB operation, or more than 1 month of discontinuation of antiplatelet therapy;
4. The position of the stent could not be determined by coronary angiography.
5. Desmovascular disease or left main artery disease;
6. Atrial fibrillation;
7. Patients with severe heart failure, valvular heart disease, renal insufficiency, severe infection and autoimmune disease.
18 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Chunjian Li
Department of cardiovascular, Director of CCU
Locations
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The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Facility Contacts
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Other Identifiers
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19
Identifier Type: -
Identifier Source: org_study_id
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