An interventional study of Percutaneous Implantation of the MAGNITUDE® Bioresorbable Arterial Scaffold in Peripheral Arterial Disease, Atherosclerotic Lesion and Lower Extremity Ischemia, sponsored by R3 Vascular Inc.. Recruiting at 7 sites in 3 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by R3 Vascular Inc. · Not applicable, Interventional, and Treatment
This first-in-human clinical feasibility study will evaluate the safety and performance of the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold and Delivery System in patients undergoing treatment for peripheral arterial disease severe enough to have significantly reduced the blood supply to their leg. The severe reduction in blood flow causes lifestyle limiting leg pain for these patients, and may lead to amputation of the affected limb due to the loss of tissue in the leg or foot from ulcers or gangrene. The investigational device being studied in this trial is intended to restore blood flow to the affected limb, providing symptomatic relief to the patient and reducing the risk of limb amputation. The scaffold is a type of vascular stent placed within the diseased artery below the knee to improve blood flow. Unlike commercially available metallic stents which are permanently placed within the artery, the MAGNITUDE® Bioresorbable scaffold is made of a polymer material that will completely dissolve away over time, providing the support necessary to the artery while it is healing after the treatment procedure and then slowly disappearing from the artery once that support is no longer needed. The investigational scaffold has been successfully used to treat vascular blockages in the coronary arteries of the heart, but the RESOLV I study will be the first time this device has been used to improve blood flow in the arteries of the lower leg. Patients enrolled in this study may have up to three vascular blockages in their lower leg arteries treated with the MAGNITUDE® Bioresorbable scaffold, and then will be assessed over the course of the following five years to evaluate whether the investigational treatment was successful in safely alleviating their leg pain and other symptoms.
The prevalence of peripheral artery disease (PAD) is estimated to be over 200 million. Critical limb ischemia (CLI) is considered the most advanced stage of PAD, occurring in about 10% of PAD patients. CLI patients typically present with ischemic rest pain, nonhealing ulcerations, infection, and/or gangrene. It is associated with a high risk of major amputation (lower limb amputations in 10% - 40% of patients at 6 months), cardiovascular events, and death (mortality rate of 20% within 6 months after the diagnosis and 50% at 5 years). A large percentage of CLI patients have occlusive disease in the infrapopliteal artery, especially in diabetics where PAD is 3 - 4 times more common. CLI related to diabetes is often more extensive, with multiple long segmental occlusions resulting in a 5 - 30-fold increase in the rate of amputations. Surgical and catheter-based revascularization procedures are typically performed to restore distal perfusion and prevent amputation in symptomatic patients.
Surgical bypass has been shown to be an effective treatment when anatomic and patient risk factors permit this approach. However, patients with CLI are often poor surgical candidates because of the absence of suitable graft vessels or the presence of significant medical comorbidities. During the past decade, therapies such as percutaneous transluminal angioplasty (PTA) and percutaneous treatment with balloons or the off-label use of coronary stents that deliver antiproliferative drugs directly to the vessel wall to inhibit neointimal hyperplasia have been on the rise and have decreased the rates of open bypass surgery.
Percutaneous transluminal angioplasty has become the first line revascularization therapy for patients with symptomatic peripheral artery disease. Published literature indicates that while uncoated balloon angioplasty has a high rate of technical success in obtaining a patent lumen, restenosis requiring repeat revascularization or amputation is common. For femoropopliteal (above the knee) disease, percutaneous treatment with a balloon that delivers an antiproliferative agent (usually paclitaxel) directly to the vessel wall inhibits neointimal hyperplasia and significantly reduces the rate of target lesion revascularization and restenosis, while maintaining a safety profile comparable to that of uncoated balloons. On the other hand, drug-coated balloon (DCB) therapy in the infrapopliteal (below the knee) arteries has not shown similarly convincing evidence of superiority over PTA, and in general, the use of DCB below the knee remains controversial.
Metallic drug-eluting stents have been shown to effective in reducing both abrupt vessel closure and restenosis rates in the management of peripheral vascular disease. However, metallic implants also negatively impact the vessel wall by permanently preventing vasomotion, autoregulation, and adaptive remodeling. In addition, there is a risk of late vessel failure due to incomplete endothelialization of the implant, stent fracture, or malapposition. Metallic implants may also cause artifacts with noninvasive imaging and complicate future revascularization procedures. Bioresorbable scaffolds provide similar mechanical properties to metallic stents during the blood vessel remodeling phase following angioplasty, while also delivering an antiproliferative drug to the site of vascular injury to minimize neointimal hyperplasia. However, once these tasks are complete, the scaffold begins a reabsorption process and eventually disappears entirely from the vessel, leaving the native artery free of any implant. For these reasons, bioresorbable scaffolds may offer a new standard for restorative therapy in the peripheral vasculature.
This first-in-human clinical feasibility study of the R3 Vascular MAGNITUDE® scaffold will evaluate the safety and performance of a bioresorbable scaffold with a thin strut design (98 µm wall thickness) and a coating of the antiproliferative drug Sirolimus for treating patients with lifestyle limiting claudication or chronic limb threatening ischemia. The objective is to perform an initial evaluation of the investigational device in a patient population undergoing percutaneous transluminal intervention with stenting for the treatment of infrapopliteal artery lesions.
The thin strut design of the MAGNITUDE® scaffold offers improved deliverability and the potential for higher vessel patency rates compared to other thicker strut bioresorbable scaffolds currently under investigation for this particular indication. In addition, compared with metallic stents, the R3 Vascular bioresorbable scaffold provides sustained support to the vessel wall following revascularization while vascular healing occurs, after which the scaffold predictably degrades leaving no permanent implant behind. The MAGNITUDE® scaffold has been shown to be biocompatible, maintain mechanical integrity over time, and provide controlled drug release through extensive validations in pre-clinical testing and clinical studies enrolling approximately 200 patients being treated for coronary artery disease.
The RESOLV I clinical investigation is a prospective, single-arm, multi-center first-in-human feasibility study of the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold and Delivery System for treating vascular disease in the infrapopliteal arteries. It will enroll a maximum of 30 patients from up to 9 investigational centers in Italy, Austria, and Canada. Eligible patients who are at least 18 years of age with lifestyle limiting claudication or chronic limb threatening ischemia (Rutherford-Becker categories 3 - 5) that elect to undergo revascularization with stenting of up to three different de novo or restenotic infrapopliteal artery lesions will be treated with the investigational device and followed for five years post-implantation.
Safety of the investigational scaffold will be assessed at 6 months as the composite rate of Major Adverse Limb Events (above ankle amputation in the index limb or major re-intervention) and peri-operative (30-day) mortality. Performance of the device will be evaluated as the primary patency rate of the treated vessels at 6 months, assessed by angiography. Multiple other angiographic, duplex ultrasound, and clinical assessments will be performed during the 5-year follow-up period.
It is expected that the subjects enrolled in this study will experience the same benefits as patients treated with the currently available coronary (used off label in the peripheral arteries) drug-eluting metallic stents. Treatment with the investigational scaffold may provide physicians with a promising alternative to permanent stenting, which has been shown to interfere with future treatments such as PTA or surgery. Additionally, since the investigational scaffold is designed to provide mechanical support to the target lesion for the required healing period post-treatment and disappear once healing is complete, this may allow for positive remodeling of the artery and reduce the risk of late complications (i.e., endothelial cell proliferation, restenosis, thrombosis, etc.).
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →R3 Vascular Inc. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Scaffold(s) must cover at least 2 mm from the pre-dilatation borders, resulting in a maximum allowed lesion length of:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subject with up to three study lesions treated by implanting a maximum of 3 R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffolds
Device: Percutaneous Implantation of the MAGNITUDE® Bioresorbable Arterial Scaffold
Placement of one or more MAGNITUDE® bioresorbable scaffolds using a percutaneous technique at one or more arterial stenoses.
(Safety) Freedom from MALE and POD
Composite endpoint of freedom from Major Adverse Limb Event ("MALE", which includes above ankle amputation in the index limb or major re-intervention) and Peri-Operative Death ("POD")
Time frame: MALE is assessed at 180 days and POD is assessed at 30 days (post implantation procedure)
(Performance) Primary Patency of the Target Lesion(s)
Freedom from hemodynamically significant stenosis by angiography (≥ 50% diameter stenosis), or duplex ultrasound (absence of flow per core lab) when angiography is not available, without additional target lesion revascularization
Time frame: Assessed at 180 days (post implantation procedure)
Technical Success
Defined as delivery and deployment of the scaffold to the target lesion resulting in a final angiographic in-lesion percent diameter stenosis ≤ 30%
Time frame: Assessed from start of treatment procedure to end of treatment procedure
Procedural Success
Defined as Technical Success without procedural Major Adverse Event (which includes thrombosis, distal embolization, or vessel rupture)
Time frame: Assessed from start of treatment procedure to hospital discharge after treatment procedure, approximately same day or day after treatment procedure
Angiographic Acute Gain
Defined as the difference between the post- and pre-procedural minimal lumen diameter within the scaffold and within the scaffolded vessel segment as assessed by angiography
Time frame: Assessed at 180 days (post implantation procedure)
Angiographic Late Lumen Loss
Defined as the difference between the post-procedural and follow-up minimal lumen diameter within the scaffold and within the scaffolded vessel segment as assessed by angiography
Time frame: Assessed at 180 days (post implantation procedure)
Angiographic Binary Restenosis
Defined as a \> 50% diameter stenosis within the scaffold and within the scaffolded vessel segment at follow-up as assessed by angiography
Time frame: Assessed at 180 days (post implantation procedure)
Duplex Ultrasound Detection of Arterial Flow
Determination of the presence or absence of blood flow within the target lesion(s) and vessel(s)
Time frame: Assessed at 1, 6, and 12 months (post implantation procedure)
All-Cause Death
Defined as patient mortality due to any cause
Time frame: Assessed at 1, 3, 6, 12, 24, 36, 48 and 60 months (post implantation procedure)
Clinically Driven Target Lesion Revascularization
Defined as revascularization for a target lesion if the target lesion diameter stenosis is \> 70% by angiography, or \> 50% and the subject has ischemia that cannot be explained by another lesion, or ≤ 50% if severe ischemic signs are attributable to the target lesion.
Time frame: Assessed at 1, 3, 6, 12, 24, 36, 48 and 60 months (post implantation procedure)
Freedom from Composite of Target Lesion Occlusion, Clinically Driven Target Lesion Revascularization, and Major Amputation
Subject has not experienced occlusion of the target lesion necessitating revascularization due to ischemic symptoms or amputation of the target limb.
Time frame: Assessed at 1, 3, 6, 12, 24, 36, 48 and 60 months (post implantation procedure)
Change in Rutherford-Becker Classification from Enrollment
Change between the pre-treatment and follow-up assessments of the symptomatic classification of the subject's chronic limb ischemia
Time frame: Assessed at 1, 3, 6, 12, 24, 36, 48 and 60 months (post implantation procedure)
Change in Ankle-Brachial Index (ABI) from Enrollment
Change between the pre-treatment and follow-up assessments of the comparison of the blood pressure measured at the ankle with the blood pressure measured at the arm to gauge the degree of arterial narrowing in the leg
Time frame: Assessed at 1, 3, 6, and 12 months (post implantation procedure)
Change in Toe-Brachial Index (TBI) from Enrollment
Change between the pre-treatment and follow-up assessments of the comparison of the blood pressure measured at the toes with the blood pressure measured at the arm to gauge the degree of arterial narrowing in the leg
Time frame: Assessed at 1, 3, 6, and 12 months (post implantation procedure)
Not enrolling at this site.
Plan to share: No
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Started Aug 2021 (actual). Primary completion is estimated for Dec 2026, 64 months after the start.
Of 125 industry-sponsored interventional studies with no phase under Peripheral Arterial Disease, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 45. This study's planned 64 months is above that.
Counting every sponsor, half of 385 studies reached it within 31 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
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R3 Vascular Inc.