LARGE-ONE: A Prospective, Multicenter, Randomized Controlled Trial of the Use of Drug-coating Balloons(DCB) or Drug-eluting Stents(DES) in the Treatment of Large Diameter Coronary Atherosclerotic Lesions
For the treatment of primary large-diameter coronary atherosclerosis through percutaneous coronary intervention (PCI), the use of a drug balloon (DCB) is not inferior to the placement of a drug-eluting stent (Firehawk™ family). \* Large-diameter vessels were defined as vessels with a diameter of ≥3.00 mm and ≤ 4.0mm
⁃ CI1. Age of subject 18-75 years old;
⁃ CI2. The subject (or legal guardian) understands and provides written informed consent to the test requirements and treatment procedures prior to performing any specific tests or procedures in the study;
⁃ CI3. The subject is suitable for percutaneous coronary intervention (PCI);
⁃ CI4. The subject had symptomatic coronary artery disease with objective evidence or asymptomatic ischemia;
⁃ CI5. Subject is willing to submit to all subsequent evaluations required by the test protocol
⁃ Angiogragh Inclusion
⁃ AI1. At Maximum 2 target lesions with stenosis ≥50%, located in no more than 2 vessels with a visual reference vessel diameter (RVD) of ≥3.00 mm and ≤4.00 mm;
⁃ AI2. The length of the target lesion must be≤35 mm (visually) and can be covered by one study stent or drug balloon;
⁃ AI3. The first target lesion must be successfully predilated/pretreated without:
• Vascular tears affecting hemodynamics (TIMI blood grade ≤2);
• Coronary dissection classified as D, E and F(ARC);
• Residual stenosis \> 30% after lesion preparation;
⁃ Note: If Type C dissection occurs at lesion predilation/preparation, clinical investigators will determine whether the target lesion can be included based on the comprehensive situation of blood flow and patients risks . Type C dissection will be excluded from the OCT subgroup considering the risk of dissection extension for OCT operation.
⁃ AI4. The anatomical conditions of the coronary artery were appropriate, and the study instrument could be transported to the appropriate location of the target lesion.