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

Completed

• Conditions: Cardiovascular Diseases

• Registration Number: NCT02725307
• Lead Sponsor: Tampere University Hospital

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-16
• Study First Submitted QC: 2016-03-27
• Study First Posted: 2016-03-31
• Status Verified: 2017-05
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulse wave change from baseline during PTA	1 hour

Secondary Outcome Measures

Name	Time	Method
Pulse wave characteristics after PTA	30 days

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland