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MOTIV Bioresorbable Scaffold in BTK Artery Disease

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ClinicalTrials.gov Identifier: NCT03987061
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Giovanni Torsello, FCRE (Foundation for Cardiovascular Research and Education)

Brief Summary:
The objective of this clinical evaluation is to evaluate the immediate and long-term (up to 12 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 40mm in length at the level of the below-the-knee arteries.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Critical Limb Ischemia Device: MOTIV BVS Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Physician-initiated Trial Investigating the MOTIV Bioresorbable Scaffold for the Treatment of Below-The-Knee Artery Disease
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Arm Intervention/treatment
Experimental: MOTIV bioresorbable vascular scaffold
MOTIV bioresorbable vascular scaffold for below-the-knee artery disease
Device: MOTIV BVS
MOTIVS BVS in below-the-knee artery disease




Primary Outcome Measures :
  1. efficacy endpoint - Primary Patency rate at 12-months post-op, based on duplex ultrasound and without target lesion revascularization. [ Time Frame: 12 months post-op ]
    Primary patency rate at 12-months, defined as no evidence of at least 50% restenosis or reocclusion within the originally treated lesion based on color-flow-duplex ultrasound (CFDU) measuring a peak systolic velocity ratio ≤2.5, and/or angiography (left at the discretion of the investigator) without target lesion revascularization (TLR) within 12 months.

  2. safety endpoint - rate of serious device-related adverse events within 30 days post-op [ Time Frame: 30 days post-op ]

Secondary Outcome Measures :
  1. Technical Success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% [ Time Frame: 1-day post-op ]
    Technical Success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%

  2. Primary Patency rate at 1 and 6 months follow-up, based on duplex ultrasound. [ Time Frame: 1 month, 6 months and 12 months post-op ]
    defined as patients that present without a hemodynamically significant restenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the given follow-up.

  3. Clinically-driven target lesion revascularization (TLR) at 1, 6 and 12-months [ Time Frame: 1 month, 6 months and 12 months post-op ]
    Clinically-driven (drop in 1 Rutherford Classification) target lesion revascularization (TLR) is defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the device/PTA edge, at 1, 6 and 12-month follow-up.

  4. Limb-Salvage rate at 1, 6 and 12 months, defined as absence of major amputation. [ Time Frame: 1 month, 6 months and 12 months post-op ]
    Major amputation is defined as amputation at or above the ankle, as opposed to minor amputation, being an amputation at or below metatarsal level, preserving functionality of the foot.

  5. Clinical success at follow-up is defined as an improvement of Rutherford classification at 1 day and 1, 6 and 12 month follow-up of one class or more as compared to the pre-procedural Rutherford Classification. [ Time Frame: 1 day post-op and 1 month, 6 months and 12 months post-op ]
  6. Serious adverse events during the study (within 12 months post-op) [ Time Frame: within 12 months post-op ]
    Serious adverse events as defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 40mm
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987061


Contacts
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Contact: Jeroen Wauters +3252252822 jeroen.wauters@fcre.eu

Sponsors and Collaborators
Prof. Giovanni Torsello
Investigators
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Study Director: Giovanni Torsello, Prof. Dr. Foundation for Cardiovascular Research and Education

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Responsible Party: Prof. Giovanni Torsello, Director, FCRE (Foundation for Cardiovascular Research and Education)
ClinicalTrials.gov Identifier: NCT03987061     History of Changes
Other Study ID Numbers: FCRE-190131
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Ischemia
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases