Clinical trial NCT03987061: MOTIV Bioresorbable Scaffold in BTK Artery Disease
Official title: Physician-initiated Trial Investigating the MOTIV™ Bioresorbable Scaffold (Reva Medical) for the Treatment of Below-The-Knee Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Critical Limb Ischemia
Lead sponsor: FCRE (Foundation for Cardiovascular Research and Education)
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Application of the MOTIV Bioresorbable Scaffold in Patients with Lesions Below-The-Knee (BTK)
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: efficacy endpoint - Primary Patency rate at 12-months post-op
timeFrame: 12 months post-op
measure: safety endpoint - rate of serious device-related adverse events within 30 days post-op
timeFrame: 30 days post-op
Secondary outcomes:
measure: Technical Success
timeFrame: 1-day post-op
measure: Primary Patency rate at follow-up visits
timeFrame: 1 month, 6 months, 12 months, 24 months and 36 months post-op
measure: Clinically-driven target lesion revascularization (TLR) at 1, 6, 12, 24 and 36-months
timeFrame: 1 month, 6 months, 12 months, 24 months and 36 months post-op
measure: Limb-Salvage rate at follow-up visits
timeFrame: 1 month, 6 months, 12 months, 24 months and 36 months post-op
measure: Clinical success at follow-up visits
timeFrame: 1 day post-op and 1 month, 6 months, 12 months, 24 months and 36 months post-op
measure: Serious adverse events during the study (within 36 months post-op)
timeFrame: within 36 months post-op
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Hospital Floridsdorf
city: Arnsberg
country: Germany
facility: Klinikum Hochsauerland
city: Bad Oeynhausen
country: Germany
facility: Bad Oeyhausen Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie
city: Berlin
country: Germany
facility: Medizinische Versorgungszentren GmbH
city: Leipzig
country: Germany
facility: University Hospital Leipzig, Angiology
city: Mainz
country: Germany
facility: Katholisches Klinikum Mainz; Akademisches Lehrkrankenhaus der Johannes Gutenberg-Universität Mainz
city: Münster
country: Germany
facility: St. Franziskus-Hospital
city: Münster
country: Germany
facility: University Hospital Münster, Angiology
Study officials:
affiliation: Foundation for Cardiovascular Research and Education
name: Giovanni Torsello, Prof. Dr.
role: STUDY_DIRECTOR
References: