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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02725307
Enrollment
30
Registered
2016-03-31
Start date
2016-03-31
Completion date
2017-05-31
Last updated
2017-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Brief summary

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

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.

Interventions

Noninvasive pulse wave sensors and ECG-sensors are attached

Sponsors

Tampere University of Technology
CollaboratorOTHER
Tampere University
CollaboratorOTHER
Tampere University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

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 -

Design outcomes

Primary

MeasureTime frame
Pulse wave change from baseline during PTA1 hour

Secondary

MeasureTime frame
Pulse wave characteristics after PTA30 days

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026