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Plug Arterial Closure System (PACS, 7F) (PACS 7F)

Primary Purpose

Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis

Status

Completed

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

Vascular access site closure (7F Ensure)

About this trial

This is an interventional treatment trial for Angioplasty, Transluminal, Percutaneous Coronary focused on measuring Closure Device, Angiography, Angioplasty, Hemostasis, Heart Catheterization, Vascular Closure, Peripheral Closure, Coronary Angiography

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Scheduled for a coronary diagnostic or interventional procedure
Able to undergo emergent vascular surgery if a complication requires it
7F arterial puncture located in the common femoral artery
Femoral artery has a lumen diameter of at least 5 mm

Exclusion Criteria:

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
Body Mass Index over 40 kg/m2
Symptomatic leg ischemia in the target limb including severe claudication or weak/absent pulse
Femoral artery diameter stenosis exceeding 50%
Pre-existing severe non-cardiac systemic disease or terminal illness
Planned arterial access at the same access site within 30 days of catheterization
Extended hospitalization (e.g. CABG surgery)
Pre-existing systemic or cutaneous infection
Prior use of an intra-aortic balloon pump through the arterial access site
Cardiogenic shock during or immediately following the catheterization
Patient is unable to ambulate at baseline
Patient is known or suspected to be pregnant or is lactating
Patient is unavailable for follow-up
Any angiographic or clinical evidence that the physician feels would place the patient at increased risk with the use of the experimental device

Sites / Locations

Hospital Almater

Outcomes

Primary Outcome Measures

Time to hemostasis following vessel access site closure

Time to ambulation following vessel access site closure

Combined rate of closure related major adverse events at 30 days

Secondary Outcome Measures

Device success (initial hemostasis 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)

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

Time patient is discharged from the hospital

Known events associated with vascular closure devices

Full Information

NCT ID

NCT00533156

First Posted

September 19, 2007

Last Updated

February 27, 2012

Sponsor

Cordis Corporation

Collaborators

Ensure Medical

1. Study Identification

Unique Protocol Identification Number

NCT00533156

Brief Title

Plug Arterial Closure System (PACS, 7F)

Acronym

PACS 7F

Official Title

Feasibility Study of the 7F Ensure Medical Plug Arterial Closure System (PACS, 7F)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Cordis Corporation

Collaborators

Ensure Medical

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Achieving hemostasis at the arterial puncture site after percutaneous cardiac catheterization is a potential cause of bleeding, hematomas, pseudoaneurysms, and various other vascular complications. Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression or the deployment of a vascular closure device. Manual compression is time consuming for the health-care provider, and painful for the patient. In addition, prolonged periods of immobilization and bed rest may be required. Vascular closure devices have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation. The Ensure Medical Vascular Closure device (VCD) is intended for femoral artery puncture site closure in patients who have undergone coronary catheterizations using a standard 7F introducer sheath. The device is comprised of a bio-absorbable plug and a plug delivery system. The plug delivery system is designed to position the bio-absorbable plug to the extravascular surface of the femoral artery access site, facilitating a hemostasis response. The Ensure Medical VCD has been studied in a prior feasibility trial of 149 patients utilizing a 6F introducer sheath, which demonstrated that: (1) the device could be used to successfully obtain rapid hemostasis and early ambulation in patients undergoing catheterization procedures; and (2) the low incidence and relatively minor nature of the observed closure related complications suggests that the device is safe for its intended purpose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Vascular access site closure (7F Ensure)

Primary Outcome Measure Information:

Title

Time to hemostasis following vessel access site closure

Time Frame

5 minutes post procedure

Title

Time to ambulation following vessel access site closure

Time Frame

Post-procedure

Title

Combined rate of closure related major adverse events at 30 days

Time Frame

Through 30 days

Secondary Outcome Measure Information:

Title

Device success (initial hemostasis within 5 minutes)

Time Frame

Within 5 minutes

Title

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

Time Frame

Through 30 days

Title

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

Time Frame

Up to hospital discharge

Title

Time patient is discharged from the hospital

Time Frame

Patient discharge

Title

Known events associated with vascular closure devices

Time Frame

Through 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Scheduled for a coronary diagnostic or interventional procedure Able to undergo emergent vascular surgery if a complication requires it 7F arterial puncture located in the common femoral artery Femoral artery has a lumen diameter of at least 5 mm Exclusion Criteria: 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 Body Mass Index over 40 kg/m2 Symptomatic leg ischemia in the target limb including severe claudication or weak/absent pulse Femoral artery diameter stenosis exceeding 50% Pre-existing severe non-cardiac systemic disease or terminal illness Planned arterial access at the same access site within 30 days of catheterization Extended hospitalization (e.g. CABG surgery) Pre-existing systemic or cutaneous infection Prior use of an intra-aortic balloon pump through the arterial access site Cardiogenic shock during or immediately following the catheterization Patient is unable to ambulate at baseline Patient is known or suspected to be pregnant or is lactating Patient is unavailable for follow-up Any angiographic or clinical evidence that the physician feels would place the patient at increased risk with the use of the experimental device

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jorge Luna, MD

Organizational Affiliation

HOSPITAL ALMATER

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Almater

City

Mexicali

State/Province

Baja California

ZIP/Postal Code

21100

Country

Mexico

12. IPD Sharing Statement

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Plug Arterial Closure System (PACS, 7F)

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