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CompletedNCT02725307Updated May 4, 2017

Non-invasive Peri- and Postoperative Monitoring of Femoral Artery Balloon Angioplasty

An observational study in Cardiovascular Diseases, sponsored by Tampere University Hospital. Completed at 1 site in Finland. Per ClinicalTrials.gov, last updated 2017-05-04.

Sponsored by Tampere University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Sex
All
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Study summary

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

Read the detailed description

Patients with stenosis of superficial femoral artery referred for percutaneous transluminal angioplasty are monitored before, during and after the procedure and pulse wave analysis is conducted.

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Conditions studied

  • Cardiovascular Diseases
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In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 30 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

  1. The patient has been clinically examined at policlinic of vascular surgery
  2. 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
  3. The patient is considered to have an indication for vascular procedure (critical limb ischemia, intermittent claudication)
  4. The patient has been examined with magnetic resonance imaging (MRA)
  5. The patient has been considered a candidate for superficial femoral artery percutaneous transluminal balloon angioplasty (PTA) and/or stenting

Exclusion criteria

Exclusion Criteria:

  1. Pacemaker
  2. Measurement disturbs or risks the subject's treatment process

Withdrawal:

  1. Emergency cases
  2. By subject's denial
  3. Inability to detect signals -
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Interventions

  • DeviceNoninvasive pulse wave analysis sensor, ECG-sensor

    Noninvasive pulse wave sensors and ECG-sensors are attached

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What researchers measure

Primary outcomes

  1. Pulse wave change from baseline during PTA

    Time frame: 1 hour

Secondary outcomes

  1. Pulse wave characteristics after PTA

    Time frame: 30 days

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Study locations

1 site
  • Tampere University Hospital
    Tampere, 33100, Finland
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02725307
Lead sponsor
Tampere University Hospital
Collaborators
Tampere University of Technology, Tampere University
Responsible party
Niku Oksala (Associate Professor (Tenure track), Tampere University Hospital) — Principal investigator
First posted
Mar 31, 2016
Start date
Mar 2016
Primary completion
May 2017
Completion
May 2017
Last update
May 4, 2017

Study contacts

Niku Oksala, Assoc. Prof.
principal investigator · Tampere University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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