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

Coronary Arteriosclerosis Clinical Trial

— ECLIPSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574691
• Other study ID #: EM 06-01EU
• Status: Completed
• Phase: Phase 1
• First received: December 13, 2007
• Last updated: February 27, 2012
• Start date: June 2007
• Est. completion date: October 2007

Study information

• Verified date: February 2012
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

• Evidence of a preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to start of femoral artery closure procedure

• Prior femoral vascular surgery or vascular graft in region of access site or contralateral common femoral artery

• The targeted femoral artery is tortuous or requires an introducer sheath length > 11 cm

• Fluoroscopically visible calcium, atherosclerotic disease, or stent = 1 cm of the puncture site that would interfere with the placement of the VCD's plug

• Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture

• Antegrade puncture

• BMI > 40 kg/m2

• Symptomatic leg ischemia in the target vessel limb including severe claudication (< 50 meter) or weak/absent pulse

• Targeted femoral artery diameter stenosis = 50%

• Pre-existing severe non-cardiac systemic disease or pre-existing terminal illness

• Planned arterial access at the same access site = 30 days following the femoral artery closure procedure

• Patient has known allergy to any materials used in the VCD

• Patient is known to require an extended hospitalization (e.g. patient is undergoing CABG surgery)

• Pre-existing systemic or cutaneous infection

• Prior or recent use of an intra-aortic balloon pump through the arterial access site

• Cardiogenic shock (hemodynamic instability requiring intravenous medications or mechanical support) experienced during or immediately post-catheterization

• Patient is unable to ambulate at baseline

• Patient is known or suspected to be pregnant, or is lactating

• Patient has already participated in this trial

• Patient has known allergy to contrast medium

• Patient is unavailable for follow-up

• Any angiographic or clinical evidence that the investigator feels would place the patient at increased risk with the use of the VCD

• Required simultaneous ipsilateral or contralateral venous puncture

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• 7F Ensure Medical Vascular Closure Device
Vascular Closure Device

Locations

Country	Name	City	State
Germany	Herz-und Diabeteszentrum NRW	Bad Oeynhausen

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to hemostasis and time to ambulation.		at time introducer sheath is removed	No
Primary	Combined rate of the following SAEs:Vascular injury or repair; access site bleeding, infection, nerve injury; ipsilateral lower extremity ischemia.		30 days	Yes
Secondary	Device success.		initial hemostasis time = 5 minutes and removal of the intact delivery system	No
Secondary	Procedural success.		30 days	Yes
Secondary	Time the patient is deemed eligible for hospital discharge.		time of the access site closure until patient is discharge	No
Secondary	Rebleeding following initial hemostasis requiring a subsequent intervention.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Pseudoaneurysm not requiring treatment.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Pseudoaneurysm treated with ultrasound-guided thrombin injection or ultrasound-guided fibrin adhesive injection.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Arteriovenous fistula documented by ultrasound or CT scan.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Access site hematoma = 6 cm.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Post-hospital discharge access site-related bleeding.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Access site-related bleeding requiring > 30 minutes to achieve hemostasis.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Ipsilateral lower extremity arterial emboli.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Transient loss of ipsilateral lower extremity pulse.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Ipsilateral deep vein thrombosis.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Access site-related vessel laceration.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Transient access site-related nerve injury		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Access site wound dehiscence.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Localized access site infection treated with oral antibiotics.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Retroperitoneal bleeding.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Ipsilateral peripheral artery total occlusion.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Ecchymosis = 6 cm.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Intraluminal plug delivery not requiring surgical intervention.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Decrease in pedal pulse.		prior to hospital discharge, and at the 30-day follow-up	Yes
Secondary	Death.		prior to hospital discharge, and at the 30-day follow-up	Yes