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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00574691
First received: December 13, 2007
Last updated: February 27, 2012
Last verified: February 2012

December 13, 2007
February 27, 2012
June 2007
Not Provided
  • Time to hemostasis and time to ambulation. [ Time Frame: at time introducer sheath is removed ] [ Designated as safety issue: No ]
  • Combined rate of the following SAEs:Vascular injury or repair; access site bleeding, infection, nerve injury; ipsilateral lower extremity ischemia. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00574691 on ClinicalTrials.gov Archive Site
  • Device success. [ Time Frame: initial hemostasis time ≤ 5 minutes and removal of the intact delivery system ] [ Designated as safety issue: No ]
  • Procedural success. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Time the patient is deemed eligible for hospital discharge. [ Time Frame: time of the access site closure until patient is discharge ] [ Designated as safety issue: No ]
  • Rebleeding following initial hemostasis requiring a subsequent intervention. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Pseudoaneurysm not requiring treatment. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Pseudoaneurysm treated with ultrasound-guided thrombin injection or ultrasound-guided fibrin adhesive injection. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Arteriovenous fistula documented by ultrasound or CT scan. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Access site hematoma ≥ 6 cm. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Post-hospital discharge access site-related bleeding. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Access site-related bleeding requiring > 30 minutes to achieve hemostasis. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Ipsilateral lower extremity arterial emboli. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Transient loss of ipsilateral lower extremity pulse. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Ipsilateral deep vein thrombosis. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Access site-related vessel laceration. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Transient access site-related nerve injury [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Access site wound dehiscence. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Localized access site infection treated with oral antibiotics. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Retroperitoneal bleeding. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Ipsilateral peripheral artery total occlusion. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Ecchymosis ≥ 6 cm. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Intraluminal plug delivery not requiring surgical intervention. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Decrease in pedal pulse. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Death. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Combined rate of the following SAEs:Vascular injury or repair; access site bleeding, infection, nerve injury; ipsilateral lower extremity ischemia. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis Trial) EU
ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis) Trial

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

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Angioplasty, Transluminal, Percutaneous Coronary
  • Coronary Arteriosclerosis
Device: 7F Ensure Medical Vascular Closure Device
Vascular Closure Device
Other Name: Ensure Medical Vascular Closure Device
1
Vascular Closure Device
Intervention: Device: 7F Ensure Medical Vascular Closure Device
Wiemer M, Langer C, Fichtlscherer S, Firschke C, Hofbauer F, Lins M, Haude M, Debèfve C, Stoll HP, Hanefeld C. First-in-man experience with a new 7F vascular closure device (EXOSEAL™): the 7F ECLIPSE study. J Interv Cardiol. 2012 Oct;25(5):518-25. doi: 10.1111/j.1540-8183.2012.00739.x. Epub 2012 Jul 5. PubMed PMID: 22762417.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
October 2007
Not Provided

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00574691
EM 06-01EU
Yes
Dr. Hans-Peter Stoll - Director Clinical Affairs, Cordis
Cordis Corporation
Not Provided
Principal Investigator: Marcus Wiemer, Dr. Herz-und Diabeteszentrum NRW
Cordis Corporation
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP