Star-Close Versus Angio-Seal for Femoral Artery Hemostasis

Percutaneous Intervention Via Femoral Artery Clinical Trial

— CLOSE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00590356
• Other study ID #: 20070208
• Status: Withdrawn
• Phase: Phase 4
• First received: December 31, 2007
• Last updated: December 6, 2016
• Start date: March 2007
• Est. completion date: June 2008

Study information

• Verified date: December 2016
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Percutaneous Intervention Via Femoral Artery

Intervention

Device:
• StarClose®
Closure device for femoral artery suture site occlusion
• AngioSeal®
Closure device for femoral artery suture site occlusion

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of major vascular complications necessitating surgical or percutaneous repair.		30-days after randomization	Yes
Secondary	The time to hemostasis.		30-days after treatment	Yes
Secondary	Procedure time.		30-days after treatment	Yes
Secondary	Device success.		30-days after treatment	Yes
Secondary	Procedure success.		30-days after treatment	Yes
Secondary	Time to ambulation.		30-days after treatment	Yes
Secondary	Time to discharge.		30-days after treatment	Yes
Secondary	Subject's comfort level during the deployment of the StarClose using the 11-point Box Scale (BS-11).		30-days after treatment	Yes