MOTIV Bioresorbable Scaffold in BTK Artery Disease

NCT ID: NCT03987061

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-05
• Study Completion Date: 2024-07-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MOTIV bioresorbable vascular scaffold

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

Group Type: EXPERIMENTAL

MOTIV BVS

Intervention Type: DEVICE

MOTIVS BVS in below-the-knee artery disease

Interventions

MOTIV BVS

MOTIVS BVS in below-the-knee artery disease

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Sabrina Overhagen

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sabrina Overhagen

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Giovanni Torsello, Prof. Dr.

Role: STUDY_DIRECTOR

Foundation for Cardiovascular Research and Education

Locations

Hospital Floridsdorf

Vienna, , Austria

Klinikum Hochsauerland

Arnsberg, , Germany

Bad Oeyhausen Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie

Bad Oeynhausen, , Germany

Medizinische Versorgungszentren GmbH

Berlin, , Germany

University Hospital Leipzig, Angiology

Leipzig, , Germany

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

Mainz, , Germany

St. Franziskus-Hospital

Münster, , Germany

University Hospital Münster, Angiology

Münster, , Germany

Countries

Austria; Germany

Other Identifiers

FCRE-190131

Identifier Type: -

Identifier Source: org_study_id