Clinical trial NCT00345631: Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device
Official title: ECLIPSE Trial - Ensure's Vascular Closure Device Speeds Hemostasis Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Angioplasty, Transluminal, Percutaneous Coronary
Coronary Arteriosclerosis
Peripheral Arteriosclerosis
Keywords: Closure Device
Angiography
Angioplasty
Hemostasis
Heart Catheterization
Peripheral Angiography
Femoral Closure
Vascular Closure
Coronary Angiography
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2006-06-28
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the Ensure Medical Vascular Closure Device is more effective than standard manual compression at sealing the puncture made in the femoral artery following a cardiac or peripheral diagnostic or interventional procedure while maintaining the same level of safety.

Detailed description: Achieving hemostasis at the arterial puncture site after percutaneous cardiac catheterization is a potential cause of bleeding, hematomas, pseudoaneurysms, and various other vascular complications. Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression or the deployment of a vascular closure device. Manual compression is time consuming for the health-care provider, and painful for the patient. In addition, prolonged periods of immobilization and bed rest may be required. Vascular closure devices have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.

The Ensure Medical Vascular Closure device (VCD) is intended for femoral artery puncture site closure in patients who have undergone coronary or peripheral diagnostic or interventional procedure using a standard 6F introducer sheath. The device is comprised of a bio-absorbable plug and a plug delivery system. The plug delivery system is designed to position the bio-absorbable plug to the extravascular surface of the femoral artery access site, facilitating a hemostasis response. The Ensure Medical VCD has been studied in a prior feasibility trial of 149 patients, which demonstrated that: (1) the device could be used to successfully obtain rapid hemostasis and early ambulation in patients undergoing catheterization procedures; and (2) the low incidence and relatively minor nature of the observed closure related complications suggests that the device is safe for its intended purpose.

The ECLIPSE Trial is designed to evaluate the safety and effectiveness of the Ensure Medical VCD in comparison to standard manual compression. Patients will be randomly assigned to have their arterial access site closed using either manual compression or the VCD. The principal comparisons of the two closure techniques will include:

* Time required to obtain hemostasis of the vascular access site
* Time required for the patient to ambulate after their catheterization
* Frequency of occurrence of serious closure-related complications

Eligibility criteria: Inclusion Criteria:

* Scheduled for a coronary or peripheral diagnostic or interventional procedure
* Able to undergo emergent vascular surgery if a complication requires it
* 6F arterial puncture located in the common femoral artery
* Femoral artery has a lumen diameter of at least 5 mm

Exclusion Criteria:

* Arterial puncture in the femoral artery of both legs
* Prior target artery closure with any vascular closure device, or closure with manual compression within 30 days prior to catheterization
* Patients who bruise or bleed easily or with a history of significant bleeding or platelet disorders
* Acute ST-elevation myocardial infarction within 48 hours prior to catheterization
* Uncontrolled hypertension at time of vessel closure
* Elevated Activated Clotting Time at time of vessel closure
* Ineligible for in-catheterization lab introducer sheath removal
* Concurrent participation in another investigational device or drug trial
* Thrombolytic therapy, bivalirudin, other thrombin-specific anticoagulants, or low molecular weight heparin within 24 hours prior to catheterization
* Preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to femoral artery closure
* Prior femoral vascular surgery or vascular graft in region of access site
* Femoral artery is tortuous or requires an introducer sheath longer than 11 cm
* Fluoroscopically visible calcium, atherosclerotic disease, or stent within 1 cm of the puncture site that would interfere with the operation of the experimental device
* Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
* Antegrade vascular puncture
* Body Mass Index over 40 kg/m\^2
* Symptomatic leg ischemia in the target limb including severe claudication or weak/absent pulse
* Femoral artery diameter stenosis exceeding 50%
* Pre-existing severe non-cardiac systemic disease or terminal illness
* Planned arterial access at the same access site within 30 days of catheterization
* Extended hospitalization (e.g. Coronary Artery Bypass Graft (CABG) surgery)
* Pre-existing systemic or cutaneous infection
* Prior use of an intra-aortic balloon pump through the arterial access site
* Cardiogenic shock during or immediately following the catheterization
* Patient is unable to ambulate at baseline
* Patient is known or suspected to be pregnant or is lactating
* Patient is unavailable for follow-up
* Any angiographic or clinical evidence that the physician feels would place the patient at increased risk with the use of the experimental device

Primary outcomes:
measure: Time to Hemostasis (TTH)
timeFrame: From when the introducer sheath was removed to the time hemostasis was first observed
measure: Time to Ambulation (TTA)
timeFrame: From when the introducer sheath was removed to 30 days post-procedure
measure: Percentage of Patients Who Experience Any Vascular Closure Related Major Adverse Events During the 30 Days Post-procedure
timeFrame: From post-procedure to 30 days follow up
Secondary outcomes:
measure: Time to Eligibility for Hospital Discharge
timeFrame: From introducer sheath removal to hospital discharge, up to 284 hours
measure: Time to Hospital Discharge
timeFrame: From introducer sheath removal to patient discharge
measure: Time to Device Deployment, up to 5 Minutes
timeFrame: From device inserted to introducer sheath removal
measure: Percentage of Patients Who Achieved Device Success Within Five Minutes Post-procedure
timeFrame: Within 5 minutes post-procedure
measure: Percent of Patients Who Achieved Procedure Success During 30 Days Post-procedure
timeFrame: From catheterization procedure to 30 day post-procedure follow up
measure: Percentage of Patients Who Experienced Any Other Vascular Closure Related Adverse Events
timeFrame: From end of vessel closure procedure to 30 days post-procedure
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Memorial Hospital
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Clearwater
country: United States
facility: Morton Plant Hosptial
state: Florida
city: Indianapolis
country: United States
facility: The Care Group
state: Indiana
city: St. Louis
country: United States
facility: Washington University School of Medicine at Barnes-Jewish Hospital
state: Missouri
city: Camden
country: United States
facility: Cooper Health Systems
state: New Jersey
city: Liverpool
country: United States
facility: SJH Cardiology Associates
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Cornell Medical College of Cornell University
state: New York
city: Raleigh
country: United States
facility: Wake Heart Research
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Philadelphia
country: United States
facility: Hahnemann Hospital
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Moffitt Heart & Vascular Group
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: New York Presbyterian Hospital
name: S. Chiu Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong SC, Bachinsky W, Cambier P, Stoler R, Aji J, Rogers JH, Hermiller J, Nair R, Hutman H, Wang H; ECLIPSE Trial Investigators. A randomized comparison of a novel bioabsorbable vascular closure device versus manual compression in the achievement of hemostasis after percutaneous femoral procedures: the ECLIPSE (Ensure's Vascular Closure Device Speeds Hemostasis Trial). JACC Cardiovasc Interv. 2009 Aug;2(8):785-93. doi: 10.1016/j.jcin.2009.06.006.