Bioresorbable Arterial Scaffold for Peripheral Artery Disease
(RESOLV I Trial)
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: R3 Vascular Inc.
Must be taking: Antiplatelet medications
Must not be taking: Immunosuppressive medications
Disqualifiers: Pregnancy, Renal insufficiency, Stroke, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests a new dissolvable stent for patients with severe leg artery blockages. The stent helps improve blood flow, releases medicine to prevent re-blockage, and then dissolves gradually. This could reduce pain and lower the risk of amputation. Bioabsorbable stents have been extensively evaluated in coronary artery disease but remain challenging and less studied in lower extremities.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on antiplatelet medications, you should not have any planned surgery or procedure that requires stopping these medications within 6 months after the procedure.
What data supports the effectiveness of the MAGNITUDE® Bioresorbable Arterial Scaffold treatment for Peripheral Artery Disease?
Research on similar bioresorbable scaffolds, like the Absorb scaffold, shows promising results in maintaining open blood vessels in complex artery conditions, with good long-term outcomes. Additionally, studies on bioresorbable scaffolds highlight their ability to provide temporary support and controlled drug release, which helps in healing and reducing artery narrowing.
12345Is the MAGNITUDE Bioresorbable Arterial Scaffold safe for humans?
Bioresorbable scaffolds, like the MAGNITUDE, are designed to provide temporary support to blood vessels and then gradually dissolve, reducing long-term risks associated with permanent implants. Studies have shown that these scaffolds are generally safe, with good healing responses observed in animal models and positive outcomes reported in human trials for similar devices.
12367What makes the MAGNITUDE® Bioresorbable Arterial Scaffold treatment unique for peripheral artery disease?
The MAGNITUDE® Bioresorbable Arterial Scaffold is unique because it is designed to be absorbed by the body over time, unlike traditional metal stents that remain permanently. This feature may reduce long-term complications and the need for future interventions.
89101112Eligibility Criteria
This trial is for adults aged 18-90 with severe peripheral arterial disease, causing leg pain or risk of limb amputation. Participants must have specific types of blockages in their lower leg arteries and agree to follow-up visits over five years. Pregnant individuals, those with recent major cardiovascular events, uncontrolled diabetes, known allergies to device materials or study medications, prior below-the-knee bypasses or stents in the target vessel are excluded.Inclusion Criteria
Any non-target leg lesions I have can be treated before my main treatment.
Subject agrees not to participate in any other investigational device or drug study for a period of at least six months following the index procedure. Questionnaire-based studies, or other studies that are non-invasive and do not require investigational devices or medications are allowed
The blood vessels being studied are between 2.5 and 3.5 millimeters wide as measured by a special imaging test.
+14 more
Exclusion Criteria
I am currently being treated for cancer or have a blood disorder.
I have severe kidney problems or am on dialysis.
I will need surgery that requires stopping blood thinners within 6 months.
+21 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold for treating infrapopliteal artery lesions
1 day
1 visit (in-person)
Initial Follow-up
Participants are monitored for safety and effectiveness, with assessments at 30 days and 180 days post-implantation
6 months
Multiple visits (in-person and virtual)
Long-term Follow-up
Participants are monitored for long-term safety and effectiveness, with assessments up to 5 years post-implantation
5 years
Annual visits (in-person and virtual)
Participant Groups
The trial tests a new MAGNITUDE® Bioresorbable Drug-Eluting Scaffold designed to dissolve over time after improving blood flow in the lower leg's diseased artery. This first-in-human study aims to alleviate symptoms and reduce amputation risks by comparing it against standard care for up to three treated vascular blockages.
1Treatment groups
Experimental Treatment
Group I: MAGNITUDE® ScaffoldExperimental Treatment1 Intervention
Subject with up to three study lesions treated by implanting a maximum of 3 R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffolds
MAGNITUDE® Bioresorbable Arterial Scaffold is already approved in United States, Canada for the following indications:
🇺🇸 Approved in United States as Magnitude scaffold for:
- Below-the-knee peripheral arterial disease (PAD)
🇨🇦 Approved in Canada as Magnitude scaffold for:
- Below-the-knee peripheral arterial disease (PAD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
CRCHUM Université MontrealMontréal, Canada
Toronto General HospitalToronto, Canada
Hopital Saint-Francois d'AssiseQuébec, Canada
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Who Is Running the Clinical Trial?
R3 Vascular Inc.Lead Sponsor
Cardiovascular Research Foundation Clinical Trials CenterCollaborator
Massachusetts General Physicians Organization / VascoreCollaborator
Cardiovascular Research Foundation, New YorkCollaborator
VasCore Vascular Ultrasound Core LabCollaborator
References
In vitro mechanical behavior and in vivo healing response of a novel thin-strut ultrahigh molecular weight poly-l-lactic acid sirolimus-eluting bioresorbable coronary scaffold in normal swine. [2020]New generation bioresorbable scaffolds (BRS) promise to improve the outcomes of current generation BRS technologies by decreasing wall thickness while maintaining structural strength. This study aimed to compare the biomechanical behavior and vascular healing profile of a novel thin-walled (98 μm) sirolimus-eluting ultrahigh molecular weight BRS (Magnitude, Amaranth Medical) to the Absorb everolimus-eluting bioresorbable vascular scaffold (Abbott Vascular).
Two-year follow-up of bioresorbable vascular scaffolds in severe infra-popliteal arterial disease. [2022]To assess the safety, efficacy, and durability of the Absorb bioresorbable vascular scaffold in predominantly complex, infra-popliteal lesions for the management of chronic limb ischemia at two-year clinical follow-up. Bioresorbable vascular scaffold are biodegradable scaffolds that provide short-term vascular support before undergoing intravascular degradation. A recent trial reported excellent 36-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb bioresorbable vascular scaffold.
Bioresorbable Scaffold-Based Controlled Drug Delivery for Restenosis. [2020]Bioresorbable scaffolds have emerged as a potential alternative to non-erodible metal implants to alleviate the long-term risk of permanent device vascular implant-related adverse events. Bioresorbable scaffolds provide a temporary mechanical support function until the vessel reaches complete healing, and the implant progressively disappears and vasomotion resumes. A polymer matrix with embedded drugs coated onto the scaffold surface degrades slowly, reducing the size from the exterior toward the interior, and this allows controlled drug release to a local vascular segment. Drug elution from a bioresorbable scaffold system is characterized by a rapid initial release that achieves high concentration along the intimal surface, which is designed to prevail vascular dilation-induced injury and formation of neointimal hyperplasia. This review highlights diverse types of bioresorbable biomaterials as vascular scaffolds, drug release kinetics, adaptive arterial wall remodeling, and complexities in the advancement of vascular scaffolds to treat restenosis.
Successful Treatment of a Subclavian Artery Stenosis With a Coronary Bioresorbable Vascular Scaffold. [2022]To report the use of a coronary bioresorbable vascular scaffold to treat subclavian artery disease.
Single arm retrospective study of bioresorbable vascular scaffolds to treat patients with severe infrapopliteal arterial disease. [2020]To assess the safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) in complex, infrapopliteal lesions for the management of chronic limb ischemia.
Comparison of a Drug-Free Early Programmed Dismantling PDLLA Bioresorbable Scaffold and a Metallic Stent in a Porcine Coronary Artery Model at 3-Year Follow-Up. [2019]Arterial Remodeling Technologies bioresorbable scaffold (ART-BRS), composed of l- and d-lactyl units without drug, has shown its safety in a porcine coronary model at 6 months. However, long-term performance remains unknown. The aim of this study was to evaluate the ART-BRS compared to a bare metal stent (BMS) in a healthy porcine coronary model for up to 3 years.
Longer Inflation Duration and Predilation-Sizing-Postdilation Improve Bioresorbable Scaffold Outcomes in a Long-term All-Comers Canadian Registry. [2019]Real-world long-term safety and efficacy of the ABSORB (Abbott Vascular, Santa Clara, CA) bioresorbable vascular scaffold has not been well characterized in the literature, particularly in the setting of acute coronary syndromes (ACS). Herein, we report outcomes up to 4 years in such a high-risk cohort, with identification of parameters associated with better outcomes.
Arterial stiffness and cumulative inflammatory burden in rheumatoid arthritis: a dose-response relationship independent of established cardiovascular risk factors. [2009]To quantify the relationship between arterial stiffness and cumulative inflammatory burden in patients with RA.
Heart-Thigh Cuff Pulse Wave Velocity: A Novel Nontechnical Measure of Arterial Stiffness. [2020]Recently, a novel index of arterial stiffness was developed to eliminate the placements of transducers on the carotid and femoral arteries and to make the measurement substantially easier. We evaluated the agreement of this new methodology with the well-established carotid-femoral pulse wave velocity (cfPWV).
Neutrophil-lymphocyte ratio is associated with arterial stiffness in patients with peritoneal dialysis. [2018]Patients with peritoneal dialysis are in the persistent inflammation state and have elevated arterial stiffness. Neutrophil-lymphocyte ratio(NLR) is a new inflammatory marker in renal and cardiac disorders. Brachial-ankle pulse wave velocity (baPWV) is a non-invasive measurement, which is widely used as a surrogate marker of arterial stiffness. However, there is little evidence to show an association between NLR and baPWV in patients with peritoneal dialysis. The aim of this cross-section study was to investigate the relationship between NLR and arterial stiffness measured by baPWV in patients with peritoneal dialysis.
Central-To-Peripheral Arterial Stiffness Gradient in Hemodialyzed Patients Depends on the Location of the Upper-limb Vascular Access. [2019]Pulse wave velocity ratio (PWV-ratio), a measure of central-to-peripheral arterial stiffness gradient, is calculated as a quotient between carotid-femoral and carotid-radial PWV (cf-PWV/cr-PWV). This new index has been reported to be significantly associated with increased mortality in hemodialyzed patients. Since several reports showed differences in arterial stiffness regarding the pathway where the vascular access (VA) is, the purpose of this research was: a) to compare arterial stiffness values obtained in the left and right sides of the body in hemodialyzed and non-hemodialyzed patients, and b) to analyze PWV-ratio values obtained on the side of the body where the VA was placed and compare them to its contralateral intact side. Since it is difficult to adequately measure cr-PWV in patients with a VA in the forearm, we measured the carotid- brachial PWV (cb-PWV) and used it to calculate PWV-ratio (cf-PWV/cb-PWV).
Non-invasive assessment of arterial stiffness indices by applanation tonometry and pulse wave analysis in patients with rheumatoid arthritis treated with TNF-alpha blocker remicade (infliximab). [2015]Rheumatoid arthritis (RA) is accompanied by long lasting inflammation, which may lead to arterial dysfunction and premature aging of the arteries. The purpose of this clinical work was to determine the modification of carotid-radial pulse wave velocity (PWV) and aortic augmentation index (AIx) in young-aged RA patients and the influence of treatment with anti-TNF-alpha (infliximab) on these measures. We examined 68 RA patients (mean age 40.68 yrs) with moderate or high disease activity (DAS28 5.37 +/- 0.94) and 87 controls (mean age 38.10 yrs). PWV and AIx were assessed non-invasively by applanation tonometry. A blood test included serum lipid profile, and high-sensitivity CRP measurements. We found that in RA patients, AIx (p