Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-24 @ 12:06 PM
NCT ID:
NCT03987061
Eligibility Criteria:
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:
1. short de novo or Restenotic lesion after PTA or
2. a short residual flow-limiting dissection or restenosis after PTA of a longer lesion
Exclusion Criteria:
* The reference segment diameter is not suitable for the available stent design
* Untreated flow-limiting aortoiliac stenotic disease
* Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment.
* Any previous surgery in the target vessel
* Aneurysm located at the target vessel
* Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
* Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 2-year life expectancy.
* Major distal amputation (above the transmetatarsal) in the study or non-study limb.
* Septicemia or bacteremia
* Any previously known coagulation disorder, including hypercoagulability
* Contraindication to anticoagulation or antiplatelet therapy
* Known allergies to scaffold or scaffold components
* Known allergies to contrast media that cannot be adequately premedicated prior to the study procedure
* Patient with known hypersensitivity to heparin-induced thrombocytopenia (HIT) type II
* Currently participating in another clinical research trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03987061
Study Brief:
Protocol Section:
NCT03987061