NCT04483791已完成4 期
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
适应症
干预措施
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
研究组 & 干预措施
DynamX Novolimus Eluting Coronary Bioadaptor System
Other
DynamX use in de novo coronary artery lesions
干预措施: DynamX Novolimus Eluting Coronary Bioadaptor System (Combination Product)
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
- Number of Participants With Clinically-Indicated Target Lesion Revascularization(12 month)
- 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)
- Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR).(1 month)
- Number of Participants With Cardiovascular and Non-Cardiovascular Death(1 month)
- Number of Participants With Cardiovascular and Non-Cardiovascular Death(6 months)
- Number of Participants With Myocardial Infarction(1 month)
- Number of Participants With Myocardial Infarction(6 months)
- Number of Participants With Clinically-Indicated Target Lesion Revascularization(1 month)
- Number of Participants With Clinically-Indicated Target Lesion Revascularization(6 month)
研究者
研究点 (4)
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