NCT02725307

Brief Summary

This study evaluates a novel noninvasive method to dynamically monitor the effect of percutaneous transluminal angioplasty on arterial pulse wave

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

March 16, 2016

Last Update Submit

May 3, 2017

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Pulse wave change from baseline during PTA

    1 hour

Secondary Outcomes (1)

  • Pulse wave characteristics after PTA

    30 days

Interventions

Noninvasive pulse wave analysis sensor, ECG-sensorDEVICE

Noninvasive pulse wave sensors and ECG-sensors are attached

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Volunteer patients with diagnosed peripheral atherosclerotic disease referred for femoral artery percutaneous transluminal angioplastu.

You may qualify if:

  • The patient has been clinically examined at policlinic of vascular surgery
  • The patient has undergone measurement of ankle-brachial index (ABI) and toe-brachial index (TBI) at policlinic of vascular surgery and exhibits abnormal ABI\<0.9 or ABI\>1.3
  • The patient is considered to have an indication for vascular procedure (critical limb ischemia, intermittent claudication)
  • The patient has been examined with magnetic resonance imaging (MRA)
  • The patient has been considered a candidate for superficial femoral artery percutaneous transluminal balloon angioplasty (PTA) and/or stenting

You may not qualify if:

  • Pacemaker
  • Measurement disturbs or risks the subject's treatment process
  • Withdrawal:
  • Emergency cases
  • By subject's denial
  • Inability to detect signals -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33100, Finland

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Niku Oksala, Assoc. Prof.

    Tampere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Tenure track)

Study Record Dates

First Submitted

March 16, 2016

First Posted

March 31, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

FI(1)