Clinical trial NCT00817349: Angio-Seal Evolution Device Registry
Official title: Clinical Registry of the St. Jude Medical Angio-Seal(TM) Evolution(TM) Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Vascular Disease
Coronary Artery Disease
Peripheral Artery Disease
Arterial Occlusive Disease
Coronary Heart Disease
Keywords: 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
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-01-06
Enrollment: 1004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Those needing a diagnostic and/or interventional catheterization procedure.

Brief summary: Collect data on the use of the Angio-Seal Evolution Device in diagnostic and interventional patient populations.

Detailed description: 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 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.

Primary outcomes:
measure: Collect major vascular complications
timeFrame: 30 days post-procedure
Secondary outcomes:
measure: Assess time artery stops bleeding
timeFrame: Immediately following procedure
measure: Collect minor vascular complications
timeFrame: 30 days post-procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Ypsilanti
country: United States
facility: Michigan Heart, P.C.
state: Michigan
city: Camden
country: United States
facility: Cooper Health System
state: New Jersey
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Grand Forks
country: United States
facility: Altru Health System Hospital
state: North Dakota
city: Columbus
country: United States
facility: Ohiohealth Research Institute @ Riverside Methodist Hospital
state: Ohio
city: Portland
country: United States
facility: Providence Health & Services
state: Oregon
city: Bryn Mawr
country: United States
facility: Main Line Health Heart Center: Bryn Mawr Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Main Line Health Heart Center: Lankenau Hospitals
state: Pennsylvania
city: Knoxville
country: United States
facility: Baptist Hospital West
state: Tennessee
Study officials:
affiliation: Wake Forest University Health Sciences
name: Robert Applegate, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Applegate RJ, Turi Z, Sachdev N, Ahmed A, Szyniszewski A, Foster M, Pratsos A, Shapiro T, Yakubov S, Shavelle D. The Angio-Seal Evolution registry: outcomes of a novel automated Angio-Seal vascular closure device. J Invasive Cardiol. 2010 Sep;22(9):420-6.