NCT01911403

Brief Summary

Clinical study in patients undergoing any intervention requiring vascular access to the femoral artery. The study compares Angio-Seal™ vs. Manual Compression with regard to control the vascular access. It is designed to demonstrate superiority of the Angio-Seal™ with an unchanged risk-profile.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2011

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
6 months until next milestone

Results Posted

Study results publicly available

March 11, 2015

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

3.7 years

First QC Date

April 14, 2011

Results QC Date

February 26, 2015

Last Update Submit

February 1, 2019

Conditions

Vascular Access Complication

Keywords

Femoral Artery puncture

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Mobilization Time Between 0-4 Hours

    Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.

    At discharge

Secondary Outcomes (6)

  • Number of Patients With Mobilization Time Between 4-48 Hours

    At discharge

  • Number of Patients With Any Complications

    At puncture closure procedure, at discharge and at follow up (2 weeks+/-1 week)

  • Number of Patients With Time to Hemostasis Between 0-4 Minutes

    At puncture closure

  • Number of Patients With Time to Hemostasis Between 4-60 Minutes

    At puncture closure

  • Time to Discharge From Interventional Radiology Department

    At discharge

  • +1 more secondary outcomes

Study Arms (2)

Angio-Seal

ACTIVE COMPARATOR

Closure procedure by Angio-Seal

Device: Angio-Seal

Manual compression

ACTIVE COMPARATOR

Closure procedure by manual compression

Procedure: Manual compression

Interventions

Manual compressionPROCEDURE

Closure procedure by Manual compression

Manual compression
Angio-SealDEVICE

Closure procedure by angio-Seal

Angio-Seal

Eligibility Criteria

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

You may qualify if:

  • Patient ≥ 18 years Interventional Radiology procedures with Femoral Artery puncture (4 French - 8 French Introducers)
  • Patient available for follow-up at 2 weeks
  • Patients who are willing to participate and have signed an Ethic Committee approved patient informed consent.

You may not qualify if:

  • Access unsuitable for use of Angio-Sea
  • Presence of calcification at the puncture site
  • Presence of visible hematoma at the end of the procedure
  • Patients who are unable to comply with the follow-up schedule based on their geographic location or for any reason.
  • Patients who are pregnant.
  • Patients currently participating in a clinical investigation that includes an active treatment arm.
  • Contraindication for ambulation at 2 hours after the end of the procedure
  • Patients with a life expectancy of less then 1 month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de São João, E.P.E.

Porto, 4202-451, Portugal

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Limitations and Caveats

This study has been early terminated on 15 May 2014 due to low enrollment rate and the publication of other larger studies about closure device versus manual compression.This lead to small number of subjects analyzed.

Results Point of Contact

Title
Dr. Paulo Morgado
Organization
Hospital de Sao Joao, E.P.E.
vilaresmorgado@iol.pt
+351 22 551 2100

Study Officials

  • Dr. Alberto Mingo, PhD.

    Hospital Universitario de La Princesa, Madrid

    PRINCIPAL INVESTIGATOR

  • Dr. Paolo Morgado, PhD.

    Hospital de São João, E.P.E.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2011

First Posted

July 30, 2013

Study Start

December 1, 2010

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

February 19, 2019

Results First Posted

March 11, 2015

Record last verified: 2019-02

Locations

PT(1)ES(1)