NCT02725307
Completed
N/A
Non-invasive Peri- and Postoperative Monitoring of Femoral Artery Balloon Angioplasty
ConditionsCardiovascular Diseases
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.
Investigators
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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