ArteriaL Fluorescence Angiography for Peripheral Arterial Disease (ALFAPAD) Study

Recruiting

• Conditions: peripheral arterial disease; atherosclerosis; 10003216

• Registration Number: NL-OMON53719
• Lead Sponsor: Medisch Spectrum Twente

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

Peripheral arterial disease patients with a Rutherford classification of 4, 5
or 6

Exclusion Criteria

Severely impaired renal function (eGFR < 30 ml/min)
Known allergy or hypersensitivity for iodine
Hyperthyroidism

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Near-infrared video-data and the quantified parameters based on<br /><br>intensity-time curves of ALFA measurements.<br /><br>2. Clinical improvement; wound healing (WIFI classification, amputation and<br /><br>walking distance (Rutherford classification) after 6 months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Technical success of ALFA measurements.<br /><br><br /><br>2. Technical success of the PAD treatment procedure.<br /><br><br /><br>3. Quantified parameters extracted from postoperative intravenous FA<br /><br>measurements.<br /><br><br /><br>4. Number of adverse events. </p><br>