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

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).

Study Overview

• Status: Withdrawn
• Conditions: Percutaneous Intervention Via Femoral Artery
• Intervention / Treatment: Device: AngioSeal®; Device: StarClose®

Detailed Description

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).

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A2; AngioSeal®	Device: AngioSeal®; Closure device for femoral artery suture site occlusion
Experimental: A1; StarClose®	Device: StarClose®; Closure device for femoral artery suture site occlusion; Other Names: StarClose® vs. AngioSeal®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Anticipated): June 1, 2008
• Study Completion (Anticipated): June 1, 2008

Study Registration Dates

• First Submitted: December 31, 2007
• First Submitted That Met QC Criteria: January 9, 2008
• First Posted (Estimate): January 10, 2008

Study Record Updates

• Last Update Posted (Estimate): December 8, 2016
• Last Update Submitted That Met QC Criteria: December 6, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Device closure
• Other Study ID Numbers: 20070208