Star-Close Versus Angio-Seal for Femoral Artery Hemostasis
CLOSE
A Randomized Comparison of Percutaneous CLip-based Vascular Occluder (Star-Close) Versus Bio-absorble Hemostatic Device (Angio-SEal) for Femoral Artery Hemostasis After Percutaneous Coronary Intervention
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This study was designed to evaluate the efficacy and safety of Starclose (Abbott Vascular Devices) for femoral access site closure in patients undergoing PCI compared to Angio-Seal STS Plus (St. Jude Medical).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 31, 2007
CompletedFirst Posted
Study publicly available on registry
January 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedDecember 8, 2016
December 1, 2016
1.3 years
December 31, 2007
December 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite of major vascular complications necessitating surgical or percutaneous repair.
30-days after randomization
Secondary Outcomes (7)
The time to hemostasis.
30-days after treatment
Procedure time.
30-days after treatment
Device success.
30-days after treatment
Procedure success.
30-days after treatment
Time to ambulation.
30-days after treatment
- +2 more secondary outcomes
Study Arms (2)
A2
ACTIVE COMPARATORAngioSeal®
A1
EXPERIMENTALStarClose®
Interventions
Closure device for femoral artery suture site occlusion
Eligibility Criteria
You may qualify if:
- The patient must be at least 18 years of age.
- Patients with appropriate arterial puncture in the common femoral artery eligible for percutaneous closure device deployment Patients undergoing PCI (only 7F sheath)
- Patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
You may not qualify if:
- Uncontrolled hypertension
- Severe peripheral vascular disease
- Severe femoral artery tortousity and calcification
- Severe obesity (BMI \> 35)
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions
- Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL.
- Patients with cardiogenic shock
- Acute MI patients within symptom onset \< 12 hours needing primary angioplasty
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
Study Sites (1)
Asan Medical Center
Seoul, 138-736, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jung Park, MD, PhD
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor, Division of Cardiology, Department of Internal Medicine
Study Record Dates
First Submitted
December 31, 2007
First Posted
January 10, 2008
Study Start
March 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
December 8, 2016
Record last verified: 2016-12