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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725307
• Other study ID #: R15107
• Status: Completed
• Phase: N/A
• First received: March 16, 2016
• Last updated: May 3, 2017
• Start date: March 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 -

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Device:
• Noninvasive pulse wave analysis sensor, ECG-sensor
Noninvasive pulse wave sensors and ECG-sensors are attached

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
Tampere University Hospital	Tampere University of Technology, University of Tampere

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse wave change from baseline during PTA		1 hour
Secondary	Pulse wave characteristics after PTA		30 days