Evaluation of WSS and Neointimal Healing Following Percutaneous Coronary Intervention of Angulated Vessels With Resolute® Integrity Zotarolimus Eluting Coronary Stent Compared to XIENCE Xpedition® Everolimus Eluting Coronary Stent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 10
- 主要终点
- In Stent Mean Cross-sectional Area of Neo-intimal Tissue Coverage
研究概览
简要总结
Stents are metallic tubular supports placed inside a blood vessel to relieve an obstruction and restore blood flow to the heart muscle. Stents could also be coated with a drug (drug-eluting stents - DES) that improves local healing and inhibits growth of scar tissue within the vessel that otherwise could lead to re-narrowing. This study will evaluate the effects of 2 FDA-approved metallic stents with different designs that may have important effects on regional plaque response and blood flow dynamics immediately after stent deployment and stent healing at 12 months follow up.
详细描述
The past two decades have registered major advances in cardiovascular medicine that have improved patients' survival and quality of life. One area of major research and innovation is the field of percutaneous coronary interventions (PCI), a non-surgical procedure used to treat a narrowed heart artery with stents. Stents are metallic tubular supports placed inside a blood vessel to relieve an obstruction and restore blood flow to the heart muscle. Stents could also be coated with a drug (drug-eluting stents - DES) that improves local healing and inhibits growth of scar tissue (smooth muscle and fibrous cells) within the vessel that otherwise could lead to re-narrowing.
The investigators study will evaluate two FDA-approved DES, currently in use, with respect to coronary vessel healing and long term patency. These include the XIENCE Xpedition Everolimus drug-eluting stent (X-EES) from Abbott Vascular and Resolute Integrity® Zotarolimus drug-eluting stent (R-ZES) from Medtronic, Inc, both of which have been shown in large clinical trials to be safe and effective. This study will evaluate the effects of apparently subtle differences in stent design between these two platforms that may have important effects on regional plaque response and blood flow dynamics immediately after stent deployment and stent healing and scar formation at 12 months follow up.
Several aspect of the R-ZES compared to the X-EES design may result in more favorable regional plaque response and blood flow dynamics immediately after stent deployment. These include a more compliant stent design made of a single sinusoidal wire with no connector between struts that is likely to be more comformable to a curved or angulated coronary vessels. In heart vessels which are not angulated, these features may not make a major difference in outcomes as studies already suggest. Whereas, in narrowed arteries which are curved or angulated, the use of X-EES could result in more straightening of the vessel's natural curvature and more disturbance in flow patterns. In contrast, the use of R-ZES in angulated arteries could cause less hemodynamic disturbances. There is a great deal of data suggesting that disturbances in local blood flow patterns and creation of eddy currents ('turbulent' blood flow) could adversely affect stent healing and exacerbate neointimal tissue growth.
Using two intravascular imaging technologies, the optical coherence tomography (OCT) and intravascular ultrasound (IVUS), this study aims to investigate differences in scar tissue coverage within the stented region and the degree of narrowing at the edges of the stent in patients undergoing clinically-indicated PCI (with R-ZES and X-EES) at 12-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be 30 to 80 years old
- •Severe coronary lesion in a vessel with ≥ 30-degree angulation requiring percutaneous coronary intervention (PCI)
- •Lesion treatable by a single Resolute Integrity or Onyx Abbott Xience Xpedition or Sierra coronary drug-eluting stent.
- •Patients with stable ischemic heart disease or acute coronary syndrome undergoing clinically PCI.
排除标准
- •Inability to provide informed consent prior to randomization
- •Anatomy requiring coronary artery bypass surgery (CABG)
- •History of prior CABG in the territory of the vessel being considered for PCI
- •Heavily calcified lesion requiring rotablation or other debulking or scoring device for successful stent deployment
- •Large thrombus burden on recent angiography
- •Previously stented vessels
- •Ostial lesions: lesion located within 5mm of the origin of the left anterior descending artery (LAD), left circumflex artery (LCx), or Right coronary artery (RCA)
- •Lesions at bifurcations and those that occlude side branches >2.5mm
- •Recent (<72 hours) ST-elevation myocardial infarction (STEMI).
- •Planned surgical procedures in the subsequent 12 months
- •History of hypersensitivity or contraindication to device materials and their degradants, everolimus, zotarolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoropolymers
- •History of any solid organ transplantation or subject is on a waiting list for any solid organ transplant
- •Left ventricular ejection fraction < 30%
- •Known allergies to clinically utilized anti-thrombotic or anti-platelet agents
- •Unable to tolerate long term dual antiplatelet therapy
- •Pregnancy or lactation
研究组 & 干预措施
Resolute Integrity DES
Resolute Integrity zotarolimus eluting stent
干预措施: Resolute Integrity Zotarolimus eluting stent (Device)
Resolute Integrity DES
Resolute Integrity zotarolimus eluting stent
干预措施: Optical Coherence Tomography (OCT) (Device)
Resolute Integrity DES
Resolute Integrity zotarolimus eluting stent
干预措施: Intravascular Ultrasound (IVUS) (Device)
Xience Xpedition DES
Xience Xpedition everolimus eluting stent
干预措施: Xience Xpedition everolimus eluting stent (Device)
Xience Xpedition DES
Xience Xpedition everolimus eluting stent
干预措施: Optical Coherence Tomography (OCT) (Device)
Xience Xpedition DES
Xience Xpedition everolimus eluting stent
干预措施: Intravascular Ultrasound (IVUS) (Device)
结局指标
主要结局
In Stent Mean Cross-sectional Area of Neo-intimal Tissue Coverage
时间窗: 1 year
Cross-sectional area in neointimal hyperplasia by Optical Coherence Tomography (OCT) at 1 year following stent placement
次要结局
- In Stent: Mean Thickness of Strut Coverage at Follow up(1 year)
- In-Stent: Degree of Vascular Straightening Post-percutaneous Coronary Intervention (PCI) (In-Stent Mechanistic Endpoint)(Immediately after stent implantation)
- In Stent: Plaque Prolapse Post-PCI (In-Stent Mechanistic Endpoint)(Immediately after stent implantation)
- In-Stent: Percent Area of Low Wall Shear Stress (WSS)-(In-Stent Mechanistic Endpoint)(Immediately after stent implantation)
- Stent Edge -Change in Plaque Area (Efficacy Endpoint) at 5 mm Proximal and Distal to Stent.(1 year)
- Stent Edge: Degree of Vascular Straightening Post-percutaneous Coronary Intervention (PCI) at the Stent Edges (Stent Edge Mechanistic Endpoint)(Immediately after stent implantation)
- Stent Edge: Percent Area With Low Wall Shear Stress (WSS) at Stent Edges Post-PCI (Mechanistic Endpoint)(Immediately after stent implantation)
