NCT00660634

Brief Summary

To investigate whether endovascular revascualrization of infrainguinal arterial obstructive disease has an effect on brachial artery reactivity

Trial Health

100
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2004

Typical duration for phase_4

Status
completed

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, 2004

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
Last Updated

April 28, 2008

Status Verified

April 1, 2008

Enrollment Period

3.3 years

First QC Date

April 10, 2008

Last Update Submit

April 25, 2008

Conditions

Peripheral Arterial Obstructive DiseaseIntermittent Claudication

Keywords

Peripheral arterial obstructive diseaseIntermittent ClaudicationEndovascular treatmentFlow-mediated dilation

Outcome Measures

Primary Outcomes (1)

  • Improvement of Flow-mediated Dilation

    4 weeks

Secondary Outcomes (1)

  • Improvement of white blood cell count

    4 weeks

Study Arms (2)

B

NO INTERVENTION

A

EXPERIMENTAL

Endovascular angioplasty/stenting

Procedure: Endovascular Revascularization

Interventions

Endovascular RevascularizationPROCEDURE

Angioplasty/Stenting of femoro-popliteal lesions

A

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Peripheral arterial disease
  • femoro-popliteal lesion
  • successful endovascular treatment of lesion

You may not qualify if:

  • persistent claudication after revascularization in arm A
  • inflammatory or neoplastic disease
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marc J Husmann, MD

    Angiology Division, University Hospital of Berne, Switzerland

    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

April 10, 2008

First Posted

April 17, 2008

Study Start

December 1, 2004

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 28, 2008

Record last verified: 2008-04