Chronic Limb-Threatening Ischemia
Conditions
Brief summary
The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Approximately 276 subjects will be randomized in a 1:1 ratio. The clinical investigation will be conducted at up to 60 clinical sites globally.
Interventions
DEVICEMAGNITUDE Sirolimus-eluting Bioresorbable Scaffold
CLTI patients treated with MAGNITUDE BRS
CLTI patients treated with PTA
Sponsors
R3 Vascular Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria 1. Subject (or their legally authorized representative) has provided written informed consent prior to any study-related procedure, using the form approved by the Institutional Review Board / Ethics Committee. 2. Subject agrees not to participate in any other investigational device or drug study for a period of at least 12 months following the index procedure. Note: Questionnaire-based studies, or other studies that are non-invasive and do not require investigational devices or medications are allowed. 3. Subject has symptomatic chronic limb-threatening ischemia, determined as Rutherford categories 4 or 5. 4. Subject is ≥ 18 years of age. 5. Subject agrees to complete all protocol-required follow-up visits, including angiograms. Angiographic Inclusion Criteria 6. Target lesion(s) in the infrapopliteal vessel(s) of the same limb located in any of the following vessels: tibioperoneal trunk (TPT), anterior tibial artery (ATA), posterior tibial artery (PTA), or peroneal artery. 7. Target lesion(s) must be located in the proximal 2/3 of the native infrapopliteal vessels and at least 10 cm above the tibio-talar joint. Note: Up to two (2) target lesions and two different arteries can be treated 8. All target lesions must be successfully crossed with a guidewire prior to randomization. Note: For CTO, retrograde crossing of the lesion is allowed but treatment must be via antegrade. Note: The most distal lesion must be treated before treating more proximal lesions. 9. Distal tibial and pedal runoff for each target lesion must be patent (free of lesions with \< 50% stenosis). If the index vessel is either anterior or posterior tibial artery, outflow must be contiguous with a patent dorsalis pedis or common plantar artery. 10. Inflow above-the-knee lesions must be treated successfully (\< 30% diameter stenosis by angiography without evidence of distal embolization, thrombus formation, or vessel rupture). Note: Inflow lesions may be treated during the index procedure prior to target lesion(s) using the standard of care (including drug-eluting devices), without wiring the target lesion, if possible. Treatment of inflow lesions in the target limb within prior 30 days is also allowed provided the treatment was successful. Note: Atherectomy of non-target lesions is not allowed. 11. Target lesion must have reference vessel diameter is between 2.75 - 3.75 mm by angiography. Vessel size measured by IVUS is highly recommended to verify RVD. 12. Target lesion(s) is de novo or restenosed ≥ 70% stenosed by angiography. Note: In-stent restenosis is an exclusion criterion. 13. The total target lesion length among all target lesions must not exceed 11 cm. 14. Minimum target lesion length must be \>14 mm. 15. Total scaffold length must not exceed 12 cm, and include at least 2 mm of normal vessel from each pre-dilatation border. 16. The target vessel must not have any other angiographic significant non-target lesions (≥ 50%). 17. Tandem non-contiguous target lesions are allowed if there is a plaque-free zone of ≥ 2 cm between the lesions. Total lesion lengths must not exceed 11 cm. 18. Target lesion(s) stenting does not block access to patent main named branches (tibioperoneal trunk (TPT), anterior tibial artery (ATA), posterior tibial artery (PTA), or peroneal artery). 19. Non-target below-the-knee lesions in non-target vessels must be successfully treated per standard of care prior to randomization without evidence of thrombosis, distal embolization, or vessel rupture. Note: Drug-eluting and atherectomy devices for treatment of non-target lesions is not allowed. 20. Subject has suitable common femoral (contralateral or antegrade ipsilateral) vascular access. Note: Retrograde pedal approach is allowed for crossing but not for treatment of target lesion(s). 21. At least one fully patent below-the-ankle artery (i.e., dorsalis pedis; common with either, lateral, or medial plantar arteries) without hemodynamically significant lesions (≥ 50% diameter stenosis by angiography) must be present in the target limb. General
Exclusion criteria
Subjects must not meet any of the following general and angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint: Freedom from MALE+POD (Major Adverse Limb Event + Peri-Operative Death) | POD at 30 Days and MALE at 6 months | Major Adverse Limb Event (MALE) includes above ankle amputation in index limb, major re-intervention on index limb at 6 months and POD includes perioperative (30-day) mortality. |
| Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency | 6 months | Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel, binary restenosis of target lesion and clinically-driven target lesion revascularization (CD-TLR). |
Countries
United States
Contacts
CONTACTMegan Hill, B.S.
CONTACTJosh Smale
PRINCIPAL_INVESTIGATOREric Secemsky, MD
Beth Israel Deaconess Medical Center
PRINCIPAL_INVESTIGATORMarianne Brodmann, MD
Medical University of Graz
PRINCIPAL_INVESTIGATORRamon L Varcoe, MD
Prince of Wales Private Hospital
Outcome results
None listed