MOTIV Bioresorbable Scaffold in BTK Artery Disease (MOTIV BVS BTK)

Dr. Sabrina Overhagen

Status

Active, not recruiting

Conditions

Critical Limb Ischemia

Peripheral Arterial Disease

Treatments

Device: MOTIV BVS

Study type

Interventional

Funder types

Other

Identifiers

NCT03987061

FCRE-190131

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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