NCT02406612已完成不适用
X-Seal 6F Vascular Closure Device EU Post-Market Clinical Follow-Up Protocol
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Time-to-Hemostasis
研究概览
简要总结
The study is designed to prospectively collect data on and confirm the safety and effectiveness of the X-Seal 6F Vascular Closure System in reducing time to hemostasis and time to ambulation for patients who have undergone diagnostic or interventional catheterization procedures using up to 6F sheaths when compared with standard compression techniques using data from literature surveys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Candidate for non-emergent diagnostic or interventional cardiac catheterization via a femoral sheath ≤6F.
- •Age ≥18 years.
- •Understand and sign the study specific written informed consent form.
- •In the investigator's opinion, the patient is suitable for the X-Seal vascular closure device, conventional hemostasis techniques and participation in an investigational trial.
- •Eligible for sheath removal in the catheterization lab.
排除标准
- •Patients who are known to be pregnant or lactating.
- •Patients who are immunocompromised.
- •Prior target artery closure with any vascular closure device or closure with manual compression win 30 days prior to this procedure.
- •Patients with significant anemia (hemoglobin <10 g/DL, Hct<30).
- •Patients who are morbidly obese or cachectic (BMI >40 or <20 kg/m2).
- •Patients with Systolic Blood Pressure >180 mmHg, unless Systolic Pressure can be lowered by pharmacological agents prior to closure
- •Patients who are currently participating in another clinical trial of an investigational drug or device that has not concluded the follow-up period.
- •Patients with a baseline INR > 1.5 (e.g. coumadin therapy).
- •Patients with a known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand's disease.
- •Patients with small femoral arteries (<4 mm), femoral artery stenosis resulting in a vessel diameter <4 mm, or patients with severe peripheral vascular disease.
- •Patients with puncture site believed to be in the profunda femoris, superficial femoral artery, or at the bifurcation of the arteries.
- •Common femoral artery with fluoroscopically visible calcium.
- •Femoral arteries that are suspected to have experienced a back wall puncture or that underwent >one (1) arterial puncture during the catheterization procedure.
- •Patients having a complication(s) at the femoral artery access site pre-sheath removal including hematoma, pseudoaneurysm, or arterio-venous fistula.
- •Patients in whom continued heparin or other anticoagulant/antiplatelet therapy is planned (with the exception of Glycoprotein IIb/IIIa receptor blockers) following completion of the catheterization procedure.
- •Patients whose ACT is >300 seconds prior to removal of the guiding catheter.
- •Patients who cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence or life threatening disease.
- •Prior femoral vascular surgery or vascular graft in region of access site.
- •Patient is unable to ambulate at baseline.
- •Acute ST-elevation MI within 48 hours prior to procedure.
- •Active systemic or cutaneous infection or inflammation
- •Patients with unilateral or bilateral lower extremity amputation
- •Patients with renal insufficiency (serum creatinine >2.5 mg/dl)
- •Patients with marked tortuosity of the femoral or iliac artery
- •Patients in whom bacterial contamination of the procedure sheath or surrounding tissues may have occurred as this may result in infection
- •Patients in whom the puncture site is located above the most inferior border of the epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma/bleed. Perform a femoral angiogram to verify the location of the puncture site
- •Patients with known allergies to beef products, collagen and/or collagen products, or polyglycolic or polylactic acid polymers
- •Patients with known allergy to stainless steel or nickel. See MRI information in the IFU.
- •Patients undergoing therapeutic thrombolysis
- •Patients punctured through a vascular graft
研究组 & 干预措施
X-Seal 6F Vascular Closure Device
Experimental
The X-Seal 6F Vascular Closure device will be used to achieve hemostasis in both diagnostic and interventional procedures using up to a 6F procedure sheath.
干预措施: X-Seal 6F Vascular Closure Device (Device)
结局指标
主要结局
Time-to-Hemostasis
时间窗: Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding, assessed up to 2 hours.
Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding.
Major Complications
时间窗: 30 days
The rate of major complications within approximately 30 days following the procedure.
次要结局
- Adverse Events(30 days)
- Time-to-Ambulation(Ambulation will be assessed 1.5 hours after removal of the access sheath for Diagnostic Patients, and 3 hours after procedure sheath removal for Interventional Patients.)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
MANTA Percutaneous Vascular Closure Device - The SAFE MANTA StudyFemoral Arteriotomy ClosureNCT02908880Essential Medical, Inc.263
已完成
不适用
European Sapheon™ Closure System Observational ProspectivE (eSCOPE) StudyVenous Insufficiency of LegNCT01570101Medtronic Endovascular70
已完成
不适用
Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European StudyVascular ClosureEndovascular ProcedureHemostasisPeripheral Vascular DiseaseNCT05027698Terumo Europe N.V.230
已完成
1 期
ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis Trial) EUAngioplasty, Transluminal, Percutaneous CoronaryCoronary ArteriosclerosisNCT00574691Cordis Corporation93
尚未招募
不适用
Safety and Performance Study for Arterial Large Hole Vascular Closure DeviceLarge Hole Percutaneous Arterial ClosureNCT05951634Vivasure Medical Limited120