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| Name | Class |
|---|---|
| BSC International Medical Trading (Shanghai) Co., Ltd. | OTHER |
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This study aims to evaluate the treatment of Chronic total occlusion (CTO) disease. Whether Intravascular Ultrasonography (IVUS) guiding the implantation of drug-eluting stents (DES) will provide better long-term clinical outcomes compared with conventional angiography
The study was a prospective, multicenter, open-label, two-arm, 1:1 randomized controlled, well-designed clinical study.
According to the sample size calculation, a total of 1448 patients with primary CTO lesions were required to participate in the study after the guide wire successfully passed through the lesion (defined as: angiographic indication that the guide wire successfully passed through the CTO lesion and reached the distal true lumen).
The study will be conducted at no more than 45research centers. With competitive enrolment, a maximum of 500 patients can be enrolled at each center or until the study is completed, whichever comes first.
It is recommended that each center enroll at least 20 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravascular ultrasound guidance | Experimental | All targeted CTO lesions will be examined and documented using a commercially available IVUS catheter (Opticross HD) according to its instructions (if not contraindicated, preoperative vasodilation with nitroglycerin to prevent spasm). IVUS examination must be performed at least once before and after stent implantation. |
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| Angiographic guidance | Active Comparator | The patient will choose the appropriate length and diameter of the stent to be implanted by visual estimation. All commercially available drug-eluting stents (except first-generation DES, such as Taxus, Excel, Partner, Firebird, etc.) can be used. DES with high quality clinical evidence is strongly recommended. The type, diameter, and length of the stent are determined by the surgeon. The stent length should be selected to ensure complete coverage of the CTO lesion. If dissection is present, additional stents are implanted. Repeat angiograms were performed immediately after surgery in the same view as before surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The guidewire successfully passed the CTO lesion | Procedure | The successful passage of the guide wire through the CTO lesion was defined as: the guide wire successfully passed through the CTO lesion and reached the distal true lumen as confirmed by angiography. Aspirin load dose (300 mg), clopidogrel load dose (300 mg), or ticagrelor load dose (180 mg) is recommended for all subjects prior to stent implantation and is recommended to be taken at least 6 hours prior to surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | All causes of death, myocardial infarction, stent thrombosis (ARC clear/probable), and clinically driven target vessel revascularization | The study design was event-driven. When a predetermined number of primary endpoints (number of MACE events = 291) occurs (expected 3 years), the study termination procedure will be initiated and this data will be used for primary end point analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiogenic death | This includes acute myocardial infarction, cardiac perforation/tamponade, arrhythmia or conduction abnormalities, cerebrovascular accidents at discharge or suspected operating-related cerebrovascular accidents, death from surgical complications, including hemorrhage, vascular repair, transfusion reaction, or bypass surgery, or any death of cardiac origin that cannot be ruled out. |
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Clinical inclusion criteria:
Inclusion criteria for angiography:
Clinical exclusion criteria:
Angiographic exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Shenyang Military Region | Recruiting | Beijing | China |
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Patients were enrolled when the guide wire successfully passed through the CTO lesion (defined as: the guide wire successfully passed through the CTO lesion and reached the distal true lumen as confirmed by angiography).
Once patients have signed the informed consent form and met all clinical and angiographic inclusion criteria and did not meet all clinical and angiographic exclusion criteria, and the guide wire has successfully passed the CTO lesion, they may be considered for participation in the study and randomized.
The random grouping arrangement is computer generated using a quasi-random number generator.
All randomized subjects will be assigned a unique identification number. Randomized replacement blocks will be used to ensure that the distribution of treatment within each layer is approximately balanced.
The study also used the Interactive Voice Response System (IVRS)/Interactive Internet Response System (IWRS) to assign subjects to the study device treatment group.
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During the study, it is difficult for researchers, operators and patients to blind the method due to objective reasons.
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| 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery |
| Nonfatal myocardial infarction | Nonfatal myocardial infarction | 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery |
| Target lesion revascularization | Target lesion revascularization is any ischemia-driven repetitive percutaneous coronary intervention to improve blood flow to a successfully treated target lesion or to bypass the target vessel and use a graft distally to the successfully treated target lesion. If the target lesion diameter is ≥50% stenosis as assessed by QCA and there is clinical or functional ischemia that cannot be explained by other coronary or graft lesions, vascularization will be considered to be induced by ischemia. | 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery |
| Target vessel revascularization | Target vessel revascularization is defined as repeated intervention in the vessel where the target lesion is located in reference to target lesion revascularization | 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery |
| Target lesion failure | Target lesion failure refers to target lesion revascularization, target vascular-related MI (Q wave and non-Q wave) or (cardiac) death due to ischemia | 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery |
| Target vessel failure | Target vessel failure refers to target vessel revascularization, target-related MI (Q wave and non-Q wave), or target-related (cardiac) death resulting from ischemia | 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery |
| Left ventricular function improved | Left ventricular ejection fraction at 1 year and changes from baseline to 1 year | Baseline period and one-year follow-up period |
| Percentage stenosis of segmental and stent diameter | Anangiographic percentage of insegment and instent diameter stenosis measured by QCA at 12 months postoperatively | The follow-up period was 12 months |
| Lumens in segmental vessels and stents were lost | 12 months postoperatively, angiographic measurements of intrasegmental and in-stent lumens by QCA were lost | The follow-up period was 12 months |
| Binary restenosis rate in segment and stent | Binary restenosis refers to the previously treated stenosis diameter at the lesion site > 50%, including the original treatment area and proximal and distal areas adjacent to the QCA analysis segment | The follow-up period was 12 months |
| Minimum lumen diameters in segments and stents | Minimum lumen diameters in segmental vessels and stents as measured by QCA 12 months postoperatively | The follow-up period was 12 months |
| QCA measurements were obtained immediately in the lumen | Immediate luminal measurements of QCA during surgery were obtained | Baseline operative period |
| MLD measured by QCA | MLD measured by QCA during surgery | Baseline operative period |
| Clinical success rate | Clinical success was defined by visual evaluation of mean lesion diameter stenosis by the physician on 2 near-orthogonal projection angiography with TIMI blood flow grade 3. No nosocomial myocardial infarction, TVR or cardiac death occurred in 30% of patients | Baseline operative period |