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

NCT00574691 | Completed Phase 1 DMC

• 1 other identifier: EM 06-01EU
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Angioplasty, Transluminal, Percutaneous Coronary; Coronary Arteriosclerosis

Keywords

Closure Device; Angiography; Angioplasty; Hemostasis; Heart Catheterization; Coronary Angiography

Outcome Measures

Primary Outcomes (2)

• Time to hemostasis and time to ambulation.

  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.

  30 days

Secondary Outcomes (23)

• 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

Study Arms (1)

1

OTHER

Vascular Closure Device

Device: 7F Ensure Medical Vascular Closure Device

Interventions

7F Ensure Medical Vascular Closure Device DEVICE

Vascular Closure Device

Also known as: Ensure Medical Vascular Closure Device

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Herz-und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Related Publications (1)

• Wiemer M, Langer C, Fichtlscherer S, Firschke C, Hofbauer F, Lins M, Haude M, Debefve 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.

  PMID: 22762417 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Marcus Wiemer, Dr.

  Herz-und Diabeteszentrum NRW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 17, 2007
• Study Start: June 1, 2007
• Study Completion: October 1, 2007
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

DE (1)