Primary coronary macrovascular disease (3.0mm<= vessel diameter <=4.0mm, lesion length <=35mm)
Conditions
Interventions
Experimental group:Drug balloon therapy
Control group:Drug stent therapy
Sponsors
Affiliated Hospital of Jining Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Clinical inclusion criteria: CI1. Subjects aged 18-75 years; CI2. The subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent before performing any specific test or procedure in the trial; CI3. Subjects are suitable for percutaneous coronary intervention (PCI); CI4. The subject has symptomatic coronary artery disease with objective evidence or asymptomatic ischemia; CI5. The subject is willing to accept all subsequent evaluations required by the protocol. Inclusion criteria for angiography: AI1. Subject has up to 2 target lesions with stenosis >=50% in up to 2 vessels with reference vessel diameter (RVD) >=3.00 mm and 30% after the first balloon dilation; Note: If type C coronary dissection occurs after predilation/pretreatment of the target lesion, clinical investigators will determine whether it can be included in the main study cohort according to the comprehensive condition of blood flow and patients, but not in the OCT subgroup. AI4. The anatomical conditions of the coronary arteries are suitable, and the research instruments can be delivered to the appropriate location of the target lesion.
Exclusion criteria
Exclusion criteria: Clinical exclusion criteria: CE1. The subject has clinical symptoms and/or ECG findings consistent with a diagnosis of acute ST-segment elevation myocardial infarction (STEMI) within 7 days; CE2. The subject is known to be allergic to contrast media (not fully pretreated) and/or concomitant drugs (e.g., cobalt-chromium alloys, platinum-chromium alloys, stainless steel, rapamycin, paclitaxel and similar configuration compounds, drug-coated carrier components, all P2Y12 receptor inhibitors, aspirin, etc.) required by the study stent system or protocol; CE3. Planned surgical treatment within 6 months after baseline surgery; CE4. Severe heart failure (NYHA grade IV) or left ventricular ejection fraction 2.0mg/dL; Or being treated with dialysis; CE6. Previous bleeding events (BARC type III or V); CE7. Subject is receiving or will be receiving long-term anticoagulant therapy for various reasons; CE8. Subjects had any of the following conditions (assessed at baseline before surgery) : ? Other serious medical conditions (e.g., cancer, congestive heart failure) that reduced the subject's life expectancy to less than 13 months; ? The subject has a current substance abuse problem (e.g., alcohol, cocaine, heroin, etc.); ? Subjects plan to undergo surgical procedures that may result in noncompliance with protocol requirements or confounding data interpretation; CE9. Subject has a history of bleeding, coagulopathy, or refusal of blood transfusion; CE10. The subject is enrolled in a clinical trial of another investigational drug or device that did not meet the primary end point; CE11. The subject plans to enroll in another investigational drug or device clinical trial within 13 months after baseline surgery; CE12. Subjects who intend to have children within 13 months of baseline surgery (fertile and sexually active women must consent to use a reliable contraceptive method from screening until 13 months after baseline surgery); CE13. Subjects were pregnant or breastfeeding women (women who may become pregnant must undergo pregnancy testing within 7 days before baseline surgery). Exclusion criteria for angiography (visual inspection) : AE1. Plan to treat 3 or more target lesions; AE2. Planned treatment of more than two major epicardial vessels; AE3. The single lesion planned for treatment cannot be covered by a single stent or a single drug balloon; AE4. The subject has two target lesions in the same target vessel, and the distance between the two target lesions is less than 15mm (visual inspection); AE5. The target lesion was located in the left main trunk. AE6. The target lesion was within 3mm of the initial segment of left anterior descending branch (LAD) or left circumflex branch (LCX). AE7. The target lesion was located in the saphenous vein graft or the artificial artery graft; AE8. Target lesions should be treated by the saphenous vein graft or artificial artery graft through the device; AE9. TIMI flow grade 0 (complete occlusion) or 1 before the target lesion was passed through the guide wire; AE10. The treatment of target lesions involves complex multi-vessel lesions (for example, bifurcation lesions require more than one stent); AE11. Target lesions involve restenosis lesions that have been implanted in the stent before, or need to overlap with previous
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late lumen loss in segment was observed 13 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical end points measured during hospitalization and at 30 days, 6 months, 12 months, and 2 years after baseline surgery;Perioperative end points;Angiographic end points measured by quantitative coronary angiography (QCA) at 13 months after baseline surgery;Optical coherence tomography (OCT) end point 3 months after baseline surgery; | — |
Countries
China
Contacts
Public ContactLijun Gan
Affiliated Hospital of Jining Medical College
Outcome results
None listed