ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis) Trial

Cordis Corporation1 site in 1 country93 target enrollmentJune 2007

ConditionsAngioplasty, Transluminal, Percutaneous Coronary Coronary Arteriosclerosis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Angioplasty, Transluminal, Percutaneous Coronary
Sponsor: Cordis Corporation
Enrollment: 93
Locations: 1
Primary Endpoint: Time to hemostasis and time to ambulation.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional procedures.

Detailed Description

Multi-center (up to 6 European sites), non-blinded, non-randomized, feasibility study with a 2-month enrollment period and 30-day clinical follow-up. 60 patients (plus up to 36 "roll-in" device training patients) undergoing diagnostic or interventional coronary or peripheral procedures utilizing a 7F arterial puncture in the common femoral artery. Patients are excluded if they have a previous target artery closure with any closure device, recent myocardial infarction or thrombolytic therapy, treatment with thrombin-specific anticoagulants or low molecular weight heparin, fluoroscopically visible calcium or atherosclerosis ≤ 1 cm of puncture site, or planned target site access ≤ 30 days.

Registry

clinicaltrials.gov

Start Date

June 2007

End Date

October 2007

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cordis Corporation

Eligibility Criteria

Inclusion Criteria

•Patient is between 18 and 85 years of age
•Patient/legal representative provides written informed consent
•Patient is scheduled for a coronary or peripheral diagnostic or interventional procedure
•Patient is able to undergo emergent vascular surgery if a complication related to the VCD necessitates such surgery
•Patient has a 7F arterial puncture located in the common femoral artery
•Target vessel has a lumen diameter ≥ 5 mm
•Patient is willing and able to complete follow-up
•Catheterization procedure is planned and elective

Exclusion Criteria

•Arterial puncture in the femoral artery of both legs
•Prior target artery closure with any closure device or closure with manual compression ≤ 30 days prior to the cardiac or peripheral catheterization procedure
•Patients with a history of significant bleeding or with any known or documented bleeding disorders, such as Thrombocytopenia (with \< 100,000 platelet count), Von Willebrand's disease, anemia (Hgb \< 10 g/dL, Hct \< 30%), thrombasthenia, decreased fibrinogen (\< 200 mg/dL), and Factor V deficiency
•Acute ST-elevation myocardial infarction ≤ 48 hours prior to the cardiac or peripheral catheterization procedure
•Uncontrolled hypertension (BP ≥ 180/110 mmHg)
•Heparinized patients with elevated pre-closure ACT level:\> 250 seconds with GP IIb/IIIa inhibitor \> 300 seconds no GP IIb/IIIa inhibitor
•Patient is ineligible for in-lab catheterization lab introducer sheath removal
•Concurrent participation in another investigational device or drug trial
•Thrombolytic therapy (e.g. streptokinase, urokinase, t-PA) ≤ 24 hours prior to the cardiac or peripheral catheterization procedure
•Angiomax (bivalirudin) or other thrombin-specific anticoagulants or low molecular weight heparin ≤ 24 hours prior to the cardiac or peripheral catheterization procedure

Outcomes

Primary Outcomes

Time to hemostasis and time to ambulation.

Time Frame: at time introducer sheath is removed

Combined rate of the following SAEs:Vascular injury or repair; access site bleeding, infection, nerve injury; ipsilateral lower extremity ischemia.

Time Frame: 30 days

Secondary Outcomes

Transient loss of ipsilateral lower extremity pulse.(prior to hospital discharge, and at the 30-day follow-up)
Ipsilateral deep vein thrombosis.(prior to hospital discharge, and at the 30-day follow-up)
Access site-related vessel laceration.(prior to hospital discharge, and at the 30-day follow-up)
Device success.(initial hemostasis time ≤ 5 minutes and removal of the intact delivery system)
Procedural success.(30 days)
Time the patient is deemed eligible for hospital discharge.(time of the access site closure until patient is discharge)
Rebleeding following initial hemostasis requiring a subsequent intervention.(prior to hospital discharge, and at the 30-day follow-up)
Pseudoaneurysm not requiring treatment.(prior to hospital discharge, and at the 30-day follow-up)
Pseudoaneurysm treated with ultrasound-guided thrombin injection or ultrasound-guided fibrin adhesive injection.(prior to hospital discharge, and at the 30-day follow-up)
Arteriovenous fistula documented by ultrasound or CT scan.(prior to hospital discharge, and at the 30-day follow-up)
Access site hematoma ≥ 6 cm.(prior to hospital discharge, and at the 30-day follow-up)
Post-hospital discharge access site-related bleeding.(prior to hospital discharge, and at the 30-day follow-up)
Access site-related bleeding requiring > 30 minutes to achieve hemostasis.(prior to hospital discharge, and at the 30-day follow-up)
Ipsilateral lower extremity arterial emboli.(prior to hospital discharge, and at the 30-day follow-up)
Transient access site-related nerve injury(prior to hospital discharge, and at the 30-day follow-up)
Access site wound dehiscence.(prior to hospital discharge, and at the 30-day follow-up)
Localized access site infection treated with oral antibiotics.(prior to hospital discharge, and at the 30-day follow-up)
Retroperitoneal bleeding.(prior to hospital discharge, and at the 30-day follow-up)
Ipsilateral peripheral artery total occlusion.(prior to hospital discharge, and at the 30-day follow-up)
Ecchymosis ≥ 6 cm.(prior to hospital discharge, and at the 30-day follow-up)
Intraluminal plug delivery not requiring surgical intervention.(prior to hospital discharge, and at the 30-day follow-up)
Decrease in pedal pulse.(prior to hospital discharge, and at the 30-day follow-up)
Death.(prior to hospital discharge, and at the 30-day follow-up)