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

Tampere University Hospital

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Device: Noninvasive pulse wave analysis sensor, ECG-sensor

Study type: Observational

Funder types: Other

Identifiers

NCT02725307

R15107

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Volunteers: No Healthy Volunteers

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 -