MOTIV Bioresorbable Scaffold in BTK Artery Disease

Peripheral Arterial Disease Clinical Trial

— MOTIV BVS BTK  

Official title:

Physician-initiated Trial Investigating the MOTIV™ Bioresorbable Scaffold (Reva Medical) for the Treatment of Below-The-Knee Artery Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03987061
• Other study ID #: FCRE-190131
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 5, 2019
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2023
• Source: FCRE (Foundation for Cardiovascular Research and Education)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• MOTIV BVS
MOTIVS BVS in below-the-knee artery disease

Locations

Country	Name	City	State
Austria	Hospital Floridsdorf	Vienna
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Sabrina Overhagen

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Technical Success	Technical Success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%	1-day post-op
Secondary	Primary Patency rate at follow-up visits	Primary patency rate 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.	1 month, 6 months, 12 months, 24 months and 36 months post-op
Secondary	Clinically-driven target lesion revascularization (TLR) at 1, 6, 12, 24 and 36-months	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	1 month, 6 months, 12 months, 24 months and 36 months post-op
Secondary	Limb-Salvage rate at follow-up visits	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.	1 month, 6 months, 12 months, 24 months and 36 months post-op
Secondary	Clinical success at follow-up visits	Clinical success at follow-up is defined as an improvement of Rutherford classification at 1 day and 1-, 6-, 12-, 24- and 36-months follow-up of one class or more as compared to the pre-procedural Rutherford Classification.	1 day post-op and 1 month, 6 months, 12 months, 24 months and 36 months post-op
Secondary	Serious adverse events during the study (within 36 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.	within 36 months post-op