Plug Arterial Closure System (PACS, 7F)

NCT00533156 | Completed Phase 2

• 1 other identifier: EMI 07-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional coronary procedures using a standard 7F introducer sheath.

Conditions

Angioplasty, Transluminal, Percutaneous Coronary; Coronary Arteriosclerosis

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Time to hemostasis following vessel access site closure

  5 minutes post procedure

• Time to ambulation following vessel access site closure

  Post-procedure

• Combined rate of closure related major adverse events at 30 days

  Through 30 days

Secondary Outcomes (5)

• Device success (initial hemostasis within 5 minutes)

  Within 5 minutes

• Procedural success on day of catheterization and at 30 days (initial hemostasis by non-randomized treatment without closure related serious adverse events)

  Through 30 days

• Time patient is deemed eligible for hospital discharge relative to their access site closure

  Up to hospital discharge

• Time patient is discharged from the hospital

  Patient discharge

• Known events associated with vascular closure devices

  Through 30 days

Interventions

Vascular access site closure (7F Ensure) DEVICE

Eligibility Criteria

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

You may qualify if:

• Scheduled for a coronary diagnostic or interventional procedure
• Able to undergo emergent vascular surgery if a complication requires it
• F arterial puncture located in the common femoral artery
• Femoral artery has a lumen diameter of at least 5 mm

You may not qualify if:

• 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

Sponsors & Collaborators

• Cordis US Corp.: lead
• Ensure Medical: collaborator

Study Sites (1)

Hospital Almater

Mexicali, Estado de Baja California, 21100, Mexico

Location

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

• Jorge Luna, MD

  HOSPITAL ALMATER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 19, 2007
• First Posted: September 21, 2007
• Study Start: July 1, 2007
• Study Completion: August 1, 2007
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

ME (1)