Angio-Seal Evolution Device Registry
This study has been completed.
Sponsor:
St. Jude Medical
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00817349
First received: January 5, 2009
Last updated: April 23, 2010
Last verified: April 2010
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Purpose
Collect data on the use of the Angio-Seal Evolution Device in diagnostic and interventional patient populations.
| Condition |
|---|
|
Peripheral Vascular Disease Coronary Artery Disease Peripheral Artery Disease Arterial Occlusive Disease Coronary Heart Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Clinical Registry of the St. Jude Medical Angio-Seal(TM) Evolution(TM) Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures |
Resource links provided by NLM:
MedlinePlus related topics:
Coronary Artery Disease
Heart Diseases
Peripheral Arterial Disease
Vascular Diseases
U.S. FDA Resources
Further study details as provided by St. Jude Medical:
Primary Outcome Measures:
- Collect major vascular complications [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Assess time artery stops bleeding [ Time Frame: Immediately following procedure ] [ Designated as safety issue: Yes ]
- Collect minor vascular complications [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: Yes ]
| Enrollment: | 1004 |
| Study Start Date: | July 2008 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
This multi-center clinical registry is designed to collect data on the use of the Angio-Seal Evolution Device in patients who have had diagnostic and/or interventional procedures through femoral artery access. Data will be collected on a patient's initial screening through hospital discharge and 30 days post-procedure to evaluate major and minor vascular complications as defined in the protocol.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Those needing a diagnostic and/or interventional catheterization procedure.
Criteria
Inclusion Criteria:
- Patient is having a diagnostic and/or interventional procedure via femoral artery access.
Exclusion Criteria:
- Patients who are unable to provide written informed consent.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817349
Locations
| United States, California | |
| Good Samaritan Hospital | |
| Los Angeles, California, United States, 90017 | |
| United States, Michigan | |
| Michigan Heart, P.C. | |
| Ypsilanti, Michigan, United States, 48197 | |
| United States, New Jersey | |
| Cooper Health System | |
| Camden, New Jersey, United States, 08103 | |
| United States, North Carolina | |
| Wake Forest University Baptist Medical Center | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, North Dakota | |
| Altru Health System Hospital | |
| Grand Forks, North Dakota, United States, 58201 | |
| United States, Ohio | |
| Ohiohealth Research Institute @ Riverside Methodist Hospital | |
| Columbus, Ohio, United States, 43214 | |
| United States, Oregon | |
| Providence Health & Services | |
| Portland, Oregon, United States, 97225 | |
| United States, Pennsylvania | |
| Main Line Health Heart Center: Bryn Mawr Hospital | |
| Bryn Mawr, Pennsylvania, United States, 19010 | |
| Main Line Health Heart Center: Lankenau Hospitals | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| United States, Tennessee | |
| Baptist Hospital West | |
| Knoxville, Tennessee, United States, 37934 | |
Sponsors and Collaborators
St. Jude Medical
Investigators
| Principal Investigator: | Robert Applegate, MD | Wake Forest University |
More Information
No publications provided by St. Jude Medical
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Vicki Bebeau, Senior Director of Clinical Research, St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT00817349 History of Changes |
| Other Study ID Numbers: | 0801 |
| Study First Received: | January 5, 2009 |
| Last Updated: | April 23, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by St. Jude Medical:
|
Angio-Seal Peripheral vascular disease Vascular closure device Arterial closure Coronary artery disease Arterial hemostasis Coronary cardiac catheterization Percutaneous coronary intervention Interventional catheterization Diagnostic catheterization |
Common femoral artery Manual compression Vascular intervention Angiogram Coronary intervention Coronary angioplasty Angiography Arteriotomy Vascular access |
Additional relevant MeSH terms:
|
Arterial Occlusive Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Vascular Diseases |
Peripheral Vascular Diseases Peripheral Arterial Disease Cardiovascular Diseases Arteriosclerosis Atherosclerosis |
ClinicalTrials.gov processed this record on May 16, 2013