A Non-Randomized, Clinical Registry of the Dynamx Novolimus Eluting Coronary Bioadaptor System in the Treatment of Patients With De Novo Native Coronary Artery Lesions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Acute Device Success
研究概览
简要总结
Prospective, non-randomized, multicenter registry
详细描述
Enrollment of up to 50 subjects with up to two de novo native coronary artery lesions measuring between 2.25 and 3.5 mm in diameter and<=34 mm in length receiving the DynamX Novolimus Eluting Coronary Bioadaptor System (CSS), with primary, interim clinical follow-up via telephone at 1 month. Follow-up will continue at 6, and 12 months. to capture cardiovascular related hospitalizations related to the study devic
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject age ≥ 18 and ≤ 80 years
- •Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
- •Indication for a percutaneous intervention with stent implantation in native epicardial arteries including patients with stable coronary artery disease and acute coronary syndromes (non-ST-elevated myocardial infarction)
- •Vessel diameter (2.25-3.5 mm) and lesions length ≤ 34 mm suitable for implantation using a single stent per lesion
- •All lesions requiring PCI should be amendable for implantation with the study stent
- •Successful pre-dilatation of the first lesion defined as no waist in the inflated pre-dilatation balloon using two orthogonal views using a pre- dilatation balloon diameter size ranging from the reference vessel diameter to 0.25 mm smaller than the reference vessel diameter, and a residual diameter stenosis prior to study device implantation by visual estimate being < 35%
排除标准
- •Target lesion / vessel specific
- •Lesions in the left main
- •Venous or arterial bypass grafts
- •In-stent restenosis
- •Chronic total occlusion
- •Ostial lesions (< 3 mm from the ostium of the RCA, LAD or Cx)
- •Stent implanted < 10 mm from the target lesion in the previous 30 days.
- •Lesion requiring rotablation or atherectomy because of, but not limited to severe calcification
- •Bifurcation lesions requiring a planned 2 or more stent technique
- •Patient specific:
- •Acute myocardial infarction with Killip Class III and IV
- •Known LVEF < 30%
- •Life expectancy < 1 year
- •Patients on renal dialysis or known GFR < 30 ml/min
- •Planned surgery necessitating interruption of dual antiplatelet therapy within the first 6 months
- •Known intolerance to components of the investigational product or medication required (e.g. intolerance to concomitant anticoagulation or antiplatelet therapy)
- •Subject is receiving or will require chronic anticoagulation therapy (e.g. coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or low molecular weight heparin)
- •Subject is currently participating in another clinical trial with an investigational drug or device that has not yet completed its primary endpoint
- •Known pregnancy or breastfeeding
- •Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason
结局指标
主要结局
Acute Device Success
时间窗: Immediately after final stent placement (intraprocedure)
Percentage of patients with an attainment of a final result of \< 30% residual stenosis using the DynamX bioadaptor with standard pre-dilatation and post-dilatation (if applicable) catheters
Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR).
时间窗: 12 Months
the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
次要结局
- Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR).(6 months)
- Number of Participants With Cardiovascular and Non-Cardiovascular Death(12 months)
- Number of Participants With Myocardial Infarction(12 months)
- Number of Participants With Clinically-Indicated Target Lesion Revascularization(12 month)