Skip to main content
OpenTrials
Completed

NCT Number: NCT02725307

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere University Hospital

Tampere, 33100, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Pacemaker
  • Measurement disturbs or risks the subject's treatment process

Withdrawal:

  • Emergency cases
  • By subject's denial
  • Inability to detect signals -

Treatment and study plan

Noninvasive pulse wave analysis sensor, ECG-sensor

Device

Noninvasive pulse wave sensors and ECG-sensors are attached

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

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Tampere University
  • Tampere University of Technology

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 31, 2016
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.