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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Noninvasive pulse wave analysis sensor, ECG-sensor

Noninvasive pulse wave sensors and ECG-sensors are attached

Intervention Type DEVICE

Eligibility Criteria

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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 -

Eligible Sex

ALL

Accepts Healthy Volunteers

No