Coronary artery disease
Conditions
Interventions
Sequent Please Neo paclitaxel coated balloon Group:Sequent Please Neo paclitaxel drug-coated balloon for dilation and drug release in CTO lesions.
Resolute Integrity Zotarolimus-eluting Stent Group:Resolute Integrity Zotarolimus-eluting stent implanted in CTO lesions.
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years, =85 years, no gender restriction 2. Patients meeting the criteria for CTO lesions (=3 months) and suitable for CTO intervention treatment; 3. After successful CTO recanalization, intravascular ultrasound confirms that the guidewire is fully positioned in the true lumen at both the proximal and distal segments of the lesion; 4. After adequate pre-treatment, coronary angiography can be performed with TIMI 3-grade antegrade flow, and no dissection affecting forward flow; 5. QFR =0.85 after lesion pre-dilation; 6. The patient is informed and agrees to participate in the clinical study and follow-up;
Exclusion criteria
Exclusion criteria: 1. After adequate pre-dilation of CTO lesions, the forward blood flow is TIMI grade 2 or below, or there is dissection affecting the forward blood flow; 2. Left main disease, graft vessel disease, in-stent restenosis; 3. Severely calcified lesions where balloon pre-dilation or rotational atherectomy failed; 4. Tortuous lesions where stent delivery is difficult; 5. Received PCI treatment within the last 6 months; 6. In-stent CTO lesions; 7. Vessel diameter =2.25mm or =4.0mm; 8. Patients with poor-quality angiograms where vessel borders cannot be detected or contrast filling is poor, excessive overlap of the stenotic segment, or severe tortuosity of the target vessel, making QFR analysis impossible; 9. Those with a tendency to bleed or contraindications to anticoagulant therapy and/or PCI, or coagulation disorders; 10. With other diseases (such as cancer, malignant tumors, congestive heart failure, organ transplants or candidates) or a history of substance abuse (alcohol, cocaine, heroin, etc.), poor compliance with the regimen, or an expected lifespan of less than 1 year; 11. Scheduled for elective surgery within the next 6 months; 12. Participants in other interventional clinical studies; 13. Subjects with poor compliance or judged unsuitable for this study by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ? Quantative Flow Reserve;The changes of CTO lesion plaque composition in the DCB group ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Late Lumen Loss at 6-month follow up;Target Lesion Failure;Major Cardiovascular Adverse Events;Procedure success; | — |
Countries
China
Contacts
Public ContactLei Ge
Zhongshan Hospital, Fudan University
Outcome results
None listed