Star-Close Versus Angio-Seal for Femoral Artery Hemostasis

NCT ID: NCT00590356

Last Updated: 2016-12-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-06-30

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).

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).

Conditions

Percutaneous Intervention Via Femoral Artery

Keywords

Device closure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A2

AngioSeal®

Group Type: ACTIVE_COMPARATOR

AngioSeal®

Intervention Type: DEVICE

Closure device for femoral artery suture site occlusion

A1

StarClose®

Group Type: EXPERIMENTAL

StarClose®

Intervention Type: DEVICE

Closure device for femoral artery suture site occlusion

Interventions

StarClose®

Closure device for femoral artery suture site occlusion

Intervention Type: DEVICE

AngioSeal®

Closure device for femoral artery suture site occlusion

Intervention Type: DEVICE

Other Intervention Names

StarClose® vs. AngioSeal®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role: collaborator

Seung-Jung Park

OTHER

Sponsor Role: lead

Responsible Party

Seung-Jung Park

professor, Division of Cardiology, Department of Internal Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Seung-Jung Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

20070208

Identifier Type: -

Identifier Source: org_study_id