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Clinical Trials/NCT02725307
NCT02725307
Completed
N/A

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

Tampere University Hospital1 site in 1 country30 target enrollmentMarch 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Tampere University Hospital
Enrollment
30
Locations
1
Primary Endpoint
Pulse wave change from baseline during PTA
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
May 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Niku Oksala

Associate Professor (Tenure track)

Tampere University Hospital

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Pulse wave change from baseline during PTA

Time Frame: 1 hour

Secondary Outcomes

  • Pulse wave characteristics after PTA(30 days)

Study Sites (1)

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