Optical Coherence Tomography (OCT) guided Percutaneous Transluminal Angiography (PTA) in lesions below the knee: a proof of concept study

Conditions: 'peripheral arterial disease' en 'intermittent claudication'
10003216

Registration Number: NL-OMON51664

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Patients of any race or sex, and any age above 18 years, who electively
undergo a single-lesion PTA of the anterior or posterior tibial artery
- The lesion is no longer than 3 cm
- Critical limb ischemia defined as Fontaine class 3 or 4
- Patients provide informed consent
- Kidney function with eGFR > 30 ml/min, allowing contrast iodine to be used
unless patient is dependent on dialysis without residual diuresis

Exclusion Criteria

- Acute limb ischemia
- Revascularization involving the same limb within 30 days prior to the index
procedure
- Known allergy to iodine contrast
- Previous implanted stent at the index site
- Previous major amputation in the same limb as the index site
- Pregnant patients

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main question to be answered is: Is OCT safe to use in PTA procedures in<br /><br>patients with critical limb ischemia in below the knee arteries in the<br /><br>Zuyderland Medical Center, and what is the effect of OCT on intraoperative<br /><br>decision-making?</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>For the secondary objectives, the following questions will be answered.<br /><br>- What is the difference in millimeters between the measured diameter of the<br /><br>vessel using OCT and the estimation of the surgeon based on DSA?<br /><br>- In what percentage of cases would intraoperative decision making have been<br /><br>altered knowing the OCT measurement in terms of balloon and stent sizing, stent<br /><br>placing and the surgical endpoint?</p><br>