NCT00481741

Brief Summary

We seek to determine if the use of the SafeSeal(TM) topical hemostasis patch is associated with reductions in time to hemostasis and time to ambulation compared to standard manual compression after arterial sheath removal following percutaneous coronary and peripheral intervention. We further seek to assess the safety of the SafeSeal patch compared to manual compression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started May 2007

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 31, 2009

Status Verified

July 1, 2009

Enrollment Period

5 months

First QC Date

June 1, 2007

Last Update Submit

July 30, 2009

Conditions

Coronary Artery DiseasePeripheral Vascular Disease

Keywords

Angioplasty, Percutaneous TransluminalCoronary

Outcome Measures

Primary Outcomes (1)

  • Time to achieve hemostasis of femoral artery after arterial sheath removal

    immediate

Secondary Outcomes (1)

  • vascular access-related bleeding complications

    prior to hospital discharge

Interventions

SafeSeal(TM) Hemostasis PatchDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient ≥ 18 years old
  • Coronary or peripheral vascular intervention
  • French arterial sheath used
  • Overnight hospitalization following procedure

You may not qualify if:

  • Hematoma or persistent bleeding around the vascular sheath
  • Previous AV fistula or pseudoaneurysm in the ipsilateral femoral artery
  • History of bleeding diathesis or coagulopathy
  • Hemoglobin level \< 9 g/dl
  • Inability to ambulate at baseline
  • Known allergy to any of the materials used in the SafeSeal
  • Female patients known to be pregnant or lactating
  • Evidence of ongoing systemic or cutaneous infection
  • Uncontrolled blood pressure following PCI (systolic blood pressure \> 180 or diastolic blood pressure \>110)
  • Current enrolment in another ongoing investigational drug/device trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseasePeripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Craig R Narins, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 1, 2007

First Posted

June 4, 2007

Study Start

May 1, 2007

Primary Completion

October 1, 2007

Study Completion

December 1, 2007

Last Updated

July 31, 2009

Record last verified: 2009-07

Locations

US(1)