Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD
NCT ID: NCT05750771
Last Updated: 2024-06-26
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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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-02-20
2025-12-20
Brief Summary
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And to develop a method to precisely identify the nature and extent of calcified lesions and to rationalize the choice of pretreatment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DCB Group
Implantation of drug-coated balloons in patients with satisfactory pretreatment
DCB
Drug-coated balloon with paclitaxel as drug coating
DES Group
Implantation of drug-eluting stents in patients with satisfactory pretreatment
DES
Second-generation drug-eluting stents
Interventions
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DES
Second-generation drug-eluting stents
DCB
Drug-coated balloon with paclitaxel as drug coating
Eligibility Criteria
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Inclusion Criteria
* 2\. meeting the indications for coronary intervention.
* 3\. IVUS examination suggests severe calcified lesions (calcification angle \> 270° at the target lesion) or OCT examination suggests severe calcified lesions (calcification angle \> 180° and/or length \> 5 mm and/or thickness \> 0.5 mm);
* 4\. Target lesion vessel diameter \> 2.5 mm
Exclusion Criteria
* 2\. unable to administer antiplatelet agents and anticoagulant therapy; have allergies to heparin, contrast agents, etc.
* 3\. the subject is participating in another uncompleted clinical trial
* 4\. life expectancy \<1 year.
* 5\. non-in situ vascular lesions.
* 6\. cardiogenic shock.
* 7\. Patients with hemodynamic instability
60 Years
ALL
No
Sponsors
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Henan Institute of Cardiovascular Epidemiology
OTHER
Responsible Party
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Principal Investigators
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Muwei Li, MD
Role: STUDY_CHAIR
Fuwai central China cardiovascular hospotial
Locations
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Fuwai central China cardiovascular Hospital
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HenanICE202303
Identifier Type: -
Identifier Source: org_study_id
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