Star-Close Versus Angio-Seal for Femoral Artery Hemostasis

Study Overview
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Brief Summary
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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).

Detailed Description
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The growing success of interventions and requirement for day case or outpatient procedures has led to a concomitant rise in the use of arteriotomy closure devices (ACD) to achieve hemostasis and allow early mobilization following arterial punctures. ACD have emerged as an alternative to traditional mechanical compression after percutaneous coronary intervention (PCI). When compared to manual compression, several studies have confirmed patient comfort, reduced time to achieve hemostasis, reduced time to ambulation, and early discharge. Recently, CLIP Trial was conducted to evaluated the safety and efficacy of the StarClose device in subjects undergoing diagnostic and interventional catheterization procedures. A total of 17 U.S. sites enrolled 596 subjects, with 483 subjects randomized at a 2:1 ratio to receive StarClose or standard compression of the arteriotomy after the percutaneous procedure. The study included roll-in (n=113), diagnostic (n=208), and interventional (n=275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. This trial demonstrated that the StarClose Vascular Closure System is noninferior to manual compression with respect to the primary safety endpoint of major vascular events in subjects who undergo percutaneous interventional procedures. StarClose significantly reduced time to hemostasis, ambulation, and dischargeability when compared with compression. However, there are no studies randomly comparing these two closure devices. Therefore, 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).

Official Title
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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

Conditions
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Percutaneous Intervention Via Femoral Artery

Intervention / Treatment
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* Device: StarClose®
* Device: AngioSeal®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A2<br>AngioSeal® | Device: AngioSeal®<br>* Closure device for femoral artery suture site occlusion<br>|
| Experimental: A1<br>StarClose® | Device: StarClose®<br>* Closure device for femoral artery suture site occlusion<br>* Other names: StarClose® vs. AngioSeal®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of major vascular complications necessitating surgical or percutaneous repair. |  | 30-days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Time to discharge. |  | 30-days after treatment | 
| Subject's comfort level during the deployment of the StarClose using the 11-point Box Scale (BS-11). |  | 30-days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Device closure