NCT00590356

WithdrawnPhase 4

Star-Close Versus Angio-Seal for Femoral Artery Hemostasis

Seung-Jung Park Source

Seung-Jung Park

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

20070208

Study Type

interventional

Actual enrollment (reported)

0

Locations

1 country

Sites

1

Timeline

Study Start

March 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2008

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 2008

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Actual enrollment (reported): 0 participants
Study completion date: June 2008
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2007
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
December 31, 2007
Actual (reported)
First Posted
January 10, 2008
Actual (reported)
Primary Completion
June 2008
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2008
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: December 8, 2016
Status Verified: December 2016
Last Update Submitted: December 6, 2016

Conditions

Percutaneous Intervention Via Femoral Artery

Keywords

Device closure

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 COMPARATOR

AngioSeal®

Device: AngioSeal®

A1

EXPERIMENTAL

StarClose®

Device: StarClose®

Interventions

StarClose®Device

Closure device for femoral artery suture site occlusion

Also known as: StarClose® vs. AngioSeal®

A1

AngioSeal®Device

Closure device for femoral artery suture site occlusion

A2

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

Seung-Jung Park
Otherlead
CardioVascular Research Foundation, Korea
Othercollaborator

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Study Officials

Seung-Jung Park, MD, PhD
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

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 2007

Date type not reported

This date has not been verified as actual or estimated.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Primary Completion

June 2008

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 2008

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

December 8, 2016

Record last verified: 2016-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00590356
Data provider: ClinicalTrials.gov
Source updated: 2016-12-08
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:16 UTC

Locations

KR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

A2

A1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations