NCT01600482已完成不适用
Clinical Investigation Plan (CIP) for Safety and Efficacy Study of Arterial Closure Device (CELT ACD). Clinical Investigation Plan No.: CIP-TS-003
Vasorum Ltd8 个研究点 分布在 3 个国家目标入组 241 人开始时间: 2012年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 241
- 试验地点
- 8
- 主要终点
- The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure.
研究概览
简要总结
The objective of the CELT ACD® Vascular Closure Device study is to evaluate the safety and effectiveness of the CELT ACD® device to achieve hemostasis of the common femoral artery access site in patients on anticoagulation who are undergoing a percutaneous intervention (PCI) procedure using a 6F sheath.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age.
- •Each patient, or his or her guardian or legal representative, is willing to give informed consent.
- •Clinically indicated for an intra-arterial procedure involving access through the common femoral artery and conducted through an access sheath size of between 6F and 7F inclusive.
排除标准
- •Patients with known allergy to any of the materials used in the device.
- •Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year.
- •Evidence of systemic bacterial or cutaneous infection, including groin infection.
- •Patients suffering with definitive or potential coagulopathy or platelet count <100,000./µl
- •Use of systemic thrombolytic agents within 24 hours prior to or during the catheterization procedure which cause the concentration of fibrinogen to be < 100 mg/dl or if post-thrombolytic fibrinogen (in case of thrombolysis within 24 hours or intra-procedural) cannot be measured.
- •Patients in whom an introducer sheath smaller than 6F or greater than 7F have been used.
- •Currently participating in another investigational device or drug study.
- •Patients with severe claudication, iliac or femoral artery diameter stenosis greater than 50%, or previous bypass surgery or stent placement in the vicinity of the access site.
- •If puncture site is via a vascular graft.
- •If a palpable haematoma is observed during the procedure.
- •Patients in whom there is any indication that puncture has been made in the profunda femorals artery or superficial femoral artery, or adjacent to the bifurcation.
- •Patients with a common femoral artery lumen diameter of less than 5 mm.
- •Patients that have any amputation from an access site limb.
- •Patients that have undergone a percutaneous procedure using a vascular closure device for hemostasis within the previous 30 days or using manual/mechanical pressure for hemostasis within the prior 30 days in the same leg.
- •Patients with a systolic blood pressure reading below 90 mmHg.
- •Patients with an active haematoma, arteriovenous fistula, or pseudoaneurysm.
- •Patients with a very superficial artery where the depth from skin to the artery surface at the access site is less than 4 mm.
- •Morbidly obese patients (Body Mass Index >35kg/m2).
- •Patients with a stent less than or equal to 1 cm of the puncture site that would interfere with placement of the device implant.
- •Patient is know or suspected to be pregnant, or is lactating.
- •Patients in whom there has been an antegrade puncture.
- •Patients in whom there has been difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial wall puncture.
- •Patients who have undergone prior or recent use of an intra-aortic balloon pump through the arterial access site.
- •Patients with uncontrolled hypertension (BP greater than or equal to 180/110mmHg) at time of vascular closure
- •Patients with acute ST-elevation myocardial infarction less than or equal to 48hours before catheterization procedure.
- •Patients with cardiogenic shock (hemodynamic instability requiring intravenous medication or mechanical support) experienced during or immediately post-catheterization.
- •Patients who are unable to ambulate at baseline.
- •Patients known to require an extended hospitalization (e.g. patient is undergoing cardiac surgery).
- •Patient has already participated in the trial.
- •Patient is unavailable for follow up.
研究组 & 干预措施
CELT ACD device
Experimental
The CELT ACD device is a vascular closure device.
干预措施: CELT ACD (Device)
Manual Compression
No Intervention
Manual Compression
结局指标
主要结局
The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure.
时间窗: With in the first 30 days +/- 7 days following the procedure
rate of major complications with in 30 +/- 7 days following the PCI procedure.
The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH)
时间窗: With in the first 30 days +/- 7 days following the procedure
Time to hemostasis
次要结局
- The Secondary Safety Endpoint Will be the Combined Rate of Minor Complications With in 30 +/- 7 Days Following Procedure.(With in the first 30 days +/- 7 days following the procedure)
- Time to Ambulation(With in the first 30 days +/- 7 days following the procedure)
- Procedure Success(30 days +/- 7 days)
- Device Success(30 days +/- 7 days)
- Time to Discharge-ability(30 days +/- 7 days)
研究者
研究点 (8)
Loading locations...
相似试验
尚未招募
不适用
Safety and Performance Study for Arterial Large Hole Vascular Closure DeviceLarge Hole Percutaneous Arterial ClosureNCT05951634Vivasure Medical Limited120
已完成
1 期
ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis Trial) EUAngioplasty, Transluminal, Percutaneous CoronaryCoronary ArteriosclerosisNCT00574691Cordis Corporation93
已完成
不适用
MANTA Percutaneous Vascular Closure Device - The SAFE MANTA StudyFemoral Arteriotomy ClosureNCT02908880Essential Medical, Inc.263
已完成
3 期
Safety and Effectiveness Study of the Ensure Medical Vascular Closure DeviceAngioplasty, Transluminal, Percutaneous CoronaryCoronary ArteriosclerosisPeripheral ArteriosclerosisNCT00345631Cordis US Corp.488
已完成
不适用
Same Day Versus Next Day Discharge: Ambulatory Closure Device Percutaneous InterventionCardiovascular DiseaseNCT01230606Icahn School of Medicine at Mount Sinai303