MOTIV Bioresorbable Scaffold in BTK Artery Disease

NCT03987061 | Unknown

• 1 other identifier: FCRE-190131
• Study Type: interventional
• Target: 58
• Locations: 2 countries
• Sites: 8

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.

Conditions

Peripheral Arterial Disease; Critical Limb Ischemia

Outcome Measures

Primary Outcomes (2)

• efficacy endpoint - Primary Patency rate at 12-months post-op

  Primary patency 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.

  12 months post-op

• safety endpoint - rate of serious device-related adverse events within 30 days post-op

  Proportion of subjects who experience serious device-related adverse events within 30 days post-procedure.

  30 days post-op

Secondary Outcomes (6)

• Technical Success

  1-day post-op

• Primary Patency rate at follow-up visits

  1 month, 6 months, 12 months, 24 months and 36 months post-op

• Clinically-driven target lesion revascularization (TLR) at 1, 6, 12, 24 and 36-months

  1 month, 6 months, 12 months, 24 months and 36 months post-op

• Limb-Salvage rate at follow-up visits

  1 month, 6 months, 12 months, 24 months and 36 months post-op

• Clinical success at follow-up visits

  1 day post-op and 1 month, 6 months, 12 months, 24 months and 36 months post-op

Study Arms (1)

MOTIV bioresorbable vascular scaffold

EXPERIMENTAL

MOTIV bioresorbable vascular scaffold for below-the-knee artery disease

Device: MOTIV BVS

Interventions

MOTIV BVS DEVICE

MOTIVS BVS in below-the-knee artery disease

MOTIV bioresorbable vascular scaffold

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• short de novo or Restenotic lesion after PTA or
• a short residual flow-limiting dissection or restenosis after PTA of a longer lesion

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Sabrina Overhagen: lead

Study Sites (8)

Hospital Floridsdorf

Vienna, Austria

Location

Klinikum Hochsauerland

Arnsberg, Germany

Location

Bad Oeyhausen Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie

Bad Oeynhausen, Germany

Location

Medizinische Versorgungszentren GmbH

Berlin, Germany

Location

University Hospital Leipzig, Angiology

Leipzig, Germany

Location

Katholisches Klinikum Mainz; Akademisches Lehrkrankenhaus der Johannes Gutenberg-Universität Mainz

Mainz, Germany

Location

St. Franziskus-Hospital

Münster, Germany

Location

University Hospital Münster, Angiology

Münster, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Giovanni Torsello, Prof. Dr.

  Foundation for Cardiovascular Research and Education

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: Application of the MOTIV Bioresorbable Scaffold in Patients with Lesions Below-The-Knee (BTK)

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 14, 2019
• Study Start: September 5, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2024
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DE (7)