Physician-initiated Trial Investigating the MOTIV™ Bioresorbable Scaffold (Reva Medical) for the Treatment of Below-The-Knee Artery Disease
Physician-initiated Trial Investigating the MOTIV™ Bioresorbable Scaffold (Reva Medical) for the Treatment of Below-The-Knee Artery Disease
The objective of this clinical evaluation is to evaluate the immediate and long-term (up to 36 months) outcome of the MOTIV™ Bioresorbable Scaffold (Reva Medical) in a controlled prospective investigation for the treatment of patients with rest pain or minor tissue loss (CLI) due to the presence of lesions of max 100mm in length at the level of the below-the-knee arteries.
Inclusion Criteria:
Patient is willing to comply with specified follow-up evaluations at the specified times
Patient presenting with rest pain or minor tissue loss (Rutherford classification from 4 to 5)
Patient is >18 years old
Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study - Patient has a projected life-expectancy of at least 24-months
Patient is eligible for treatment with the MOTIV™ Bioresorbable Scaffold
Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
De novo lesion or Restenotic lesion after PTA in the infrapopliteal arteries, suitable for endovascular therapy
Target vessel diameter visually estimated to be ≥2.5mm and ≤3.50mm
Guidewire and delivery system successfully traversed the lesion
Total target lesion is maximally 100mm
Definition of Target Lesion is:
Exclusion Criteria:
Bad Oeynhausen, Germany
Mainz, Germany