Status:
ACTIVE_NOT_RECRUITING
Paclitaxel-Coated Balloon Versus Zotarolimus-Eluting Stent for Treatment of De Novo Coronary Artery Lesions
Lead Sponsor:
Xijing Hospital
Conditions:
De Novo Stenosis
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Coronary restenosis has been one of the main reasons affecting the prognosis of patients with coronary artery disease (CAD) after percutaneous coronary intervention (PCI). With drug-eluting stents (DE...
Eligibility Criteria
Inclusion
- 18y ≤ age ≤ 80y;
- De-novo coronary artery lesions with an indication for PCI;
- Target lesion diameter stenosis ≥ 70% (visual) or ≥ 50% (visual) with evidence of ischemia;
- Target lesion reference vessel diameter (2.5mm-4.0 mm), Length of a single target lesion ≤ 35mm; Total treated lesion length ≤ 60 mm;
- Vessels treated ≤ 2; only one DCB/DES is allowed for each target vessel;
- ≤ 2 non-target lesions (non-TL) are allowed, and can not be in the same vessel as the target lesion (randomization should be implemented only after the successful treatment of all non-TL);
- Patients who are able to complete the follow-up and compliant to the prescribed medication.
Exclusion
- Myocardial infarction (\< 7 days);
- Heavy thrombotic burden in target vessel;
- eGFR \< 30ml/min or hemodialysis patients;
- Other cardiovascular and cerebrovascular procedures planned within 12 months after index PCI;
- Patients with contraindications to antiplatelet agents and anticoagulants or bleeding tendency, history of active peptic ulcer, and stroke within 6 months;
- Life expectancy of less than 1 years;
- Patient is a woman who is pregnant or nursing;
- Known allergic to medications such as Aspirin, Heparin, antiplatelet drugs, paclitaxel, or contrast; patients with systemic lupus erythematosus or other systemic immune diseases;
- Chronic total occlusion lesion;
- Unprotected left main disease;
- Bifurcation lesion requiring 2 stents;
- Ostial lesions, distance from left main ≤ 2mm;
- Severe calcification or distortion;
- Arterial, venous or prosthetic grafts;
- In-stent stenosis requiring revascularization (defined as stenosis≥50% by visual or positive functional assessments in any vessel);
- Myocardial bridging located at target lesions;
- Currently participating in another trial and not yet at its primary endpoint;
- Participants deemed unsuitable to be enrolled by investigators for unable to comply with protocol or other reasons.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2025
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT05209412
Start Date
February 1 2022
End Date
February 1 2025
Last Update
January 24 2024
Active Locations (1)
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1
Ling Tao
Xi'an, Shannxi, China, 710032