Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device

Coronary Arteriosclerosis Clinical Trial

Official title:

ECLIPSE Trial - Ensure's Vascular Closure Device Speeds Hemostasis Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345631
• Other study ID #: EM0501
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2006
• Last updated: May 25, 2012
• Start date: February 2007
• Est. completion date: September 2007

Study information

• Verified date: May 2012
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioplasty, Transluminal, Percutaneous Coronary
• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia
• Peripheral Arteriosclerosis

Intervention

Other:
• Manual Compression
Manual compression

Device:
• Vascular Closure Device
Investigational vascular closure device

Locations

Country	Name	City	State
United States	Cooper Health Systems	Camden	New Jersey
United States	Morton Plant Hosptial	Clearwater	Florida
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Baylor Research Institute	Dallas	Texas
United States	The Care Group	Indianapolis	Indiana
United States	SJH Cardiology Associates	Liverpool	New York
United States	New York Presbyterian Hospital - Cornell Medical College of Cornell University	New York	New York
United States	Hahnemann Hospital	Philadelphia	Pennsylvania
United States	Mayo Clinic Hospital	Phoenix	Arizona
United States	Wake Heart Research	Raleigh	North Carolina
United States	Sutter Memorial Hospital	Sacramento	California
United States	University of California Davis Medical Center	Sacramento	California
United States	LDS Hospital	Salt Lake City	Utah
United States	Swedish Medical Center	Seattle	Washington
United States	Washington University School of Medicine at Barnes-Jewish Hospital	St. Louis	Missouri
United States	Stanford University	Stanford	California
United States	Moffitt Heart & Vascular Group	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 hemos — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Hemostasis (TTH)	Time to hemostasis is defined as time (in minutes) from when the introducer sheath was removed to the time that hemostasis was first observed during post-procedure follow up. Hemostasis is defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma. Time to hemostasis is one of the two co-primary endpoints.	From when the introducer sheath was removed to the time hemostasis was first observed	No
Primary	Time to Ambulation (TTA)	Time to ambulation is defined as the time from when the introducer sheath was removed to the time that ambulation was achieved. Ambulation is defined as patient standing and walking at least 20 feet without re-bleeding or significant oozing requiring manual compression. Time to ambulation is one of the two co-primary endpoints.	From when the introducer sheath was removed to 30 days post-procedure	No
Primary	Percentage of Patients Who Experience Any Vascular Closure Related Major Adverse Events During the 30 Days Post-procedure	Vascular closure related major adverse events consist of any of the events below: Vascular repair or the need for repair; access site-related bleeding requiring transfusion; access site-related infection requiring intravenous/intramuscular antibiotics and/or extended hospitalization; any new ipsilateral lower extremity ischemia documented by symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram; surgery for access site-related nerve injury; and Permanent (> 30 days) access site-related nerve injury.	From post-procedure to 30 days follow up	Yes
Secondary	Time to Eligibility for Hospital Discharge	Time to Eligibility for Hospital Discharge is measured from the time of sheath removal to the time when the patient is eligible for discharge according to the judgment of the patient's physician.	From introducer sheath removal to hospital discharge, up to 284 hours	Yes
Secondary	Time to Hospital Discharge	Time to hospital discharge is defined as from the time of sheath removal to the time of hospital discharge	From introducer sheath removal to patient discharge	No
Secondary	Time to Device Deployment, up to 5 Minutes	Time to device deployment is defined as from the time device inserted to the time sheath removed	From device inserted to introducer sheath removal	No
Secondary	Percentage of Patients Who Achieved Device Success Within Five Minutes Post-procedure	Device Success is defined as the successful deployment of the plug, initial hemostasis time less or equal to 5 minutes, and removal of the intact delivery system.	Within 5 minutes post-procedure	No
Secondary	Percent of Patients Who Achieved Procedure Success During 30 Days Post-procedure	Procedure success is defined as initial hemostasis achieved by the assigned method Vascular Closure Device (VCD) or Manual compression (MC) with none of the primary safety endpoint's closure related major adverse events (MAE). Procedural success is assessed on day of catheterization procedure and at 30 days post-procedure.	From catheterization procedure to 30 day post-procedure follow up	No
Secondary	Percentage of Patients Who Experienced Any Other Vascular Closure Related Adverse Events	Other known vascular closure related adverse events include: Rebleeding Following Initial Hemostasis; Access Site Hematoma >= 6cm; Access Site-Related Bleeding Requiring > 30 min for Hemostasis; Transient Access Site-Related Nerve Injury; Retroperitonea Bleeding; Decrease in Pedal Pulse	From end of vessel closure procedure to 30 days post-procedure	Yes