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Bioresorbable Arterial Scaffold for Peripheral Artery Disease (RESOLV I Trial)
RESOLV I Trial Summary
This trial will evaluate the safety and performance of the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in patients with PAD. The scaffold is made of a polymer material that will dissolve over time. Patients will be assessed over the course of five years to evaluate the success of the treatment.
RESOLV I Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRESOLV I Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RESOLV I Trial Design
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Who is running the clinical trial?
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- Any non-target leg lesions I have can be treated before my main treatment.I am currently being treated for cancer or have a blood disorder.The blood vessels being studied are between 2.5 and 3.5 millimeters wide as measured by a special imaging test.I have severe kidney problems or am on dialysis.I will need surgery that requires stopping blood thinners within 6 months.I have severe foot problems, including bone infection or gangrene.You are expected to live for less than one year.I have an aneurysm or a recent clot in my aorta or leg arteries.I agree to attend all required follow-up visits and tests.I have had a bypass surgery below the knee on the affected limb.My treatment involves supporting both branches of a bifurcated lesion.I have at least one open artery below my ankle without major blockages.My most distant lesion was crossed with a wire for treatment.I had a procedure to improve blood flow in a specific blood vessel within the last 3 months.You have other health or personal problems that may make it hard for you to take part in the study or follow the instructions. This includes having had COVID-19 recently.The blood vessels being studied have other blockages that could affect blood flow.I have a surgery or procedure planned within the next month, except for minor amputations.My lesions cannot be opened with initial treatment.You have had a stent placed in the area being studied or have a stent in the blood vessel being looked at.I have up to three new or recurring blockages in my lower leg arteries.You need to have a certain type of blood vessel in your leg that the doctors can use to give you the treatment. They cannot use blood vessels in your wrist or foot.I have given my written consent to participate in the study.My artery was prepared for treatment with a special balloon and is less than half blocked.Criterion: The stent(s) must cover at least 2 mm beyond the edges of the narrowed blood vessel. The maximum allowed length of the treated area is 14 mm for one 18 mm stent, 31 mm for two overlapping 18 mm stents, 47 mm for three overlapping 18 mm stents, 34 mm for one 38 mm stent, and 51 mm for one 38 mm stent with one overlapping 18 mm stent.I am on immunosuppression therapy or have an autoimmune disease.I currently have an infection that affects my whole body.I have severe leg pain or risk of losing my limb due to poor blood flow.Any blockages in my leg above the knee have been treated.I am not incapacitated and can make my own decisions.I cannot walk by myself.My diabetes is not under control, with an HbA1c level over 10%.I had a stroke or heart attack within the last 3 months.I have had a major limb amputation.I am allergic to certain materials or medications used in the study.Your body mass index (BMI) is less than 18.I am between 18 and 90 years old.Each patient can have up to three 18 mm scaffolds, or one 38 mm scaffold, or one 18 mm scaffold and one 38 mm scaffold implanted.My lesion is in the upper part of my lower leg's vessels, away from the ankle.My heart condition allows for specific treatment with up to three supports.
- Group 1: MAGNITUDE® Scaffold
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the protocol for this research involve minors?
"This clinical trial requires participants to be aged 18 and above, but less than 90 years old."
Are new participants enrolling in this investigation presently?
"This clinical study, which was first published on August 17th 2021 and last modified on May 12th 2022 is presently recruiting participants."
What are the desired outcomes of this experiment?
"The study's primary outcome, which will be examined over a 180-day period post implantation procedure (POD), is the Primary Patency of the Target Lesion(s). Technical Success, Procedural Success, and Angiographic Late Lumen Loss are all secondary outcomes that must also be tracked. Technical Success is defined as successful delivery and deployment of the scaffold with an in-lesion percent diameter stenosis ≤ 30%, while Procedural Success requires this to occur without any Major Adverse Events such as thrombosis, vessel rupture or distal embolization. Lastly, Angiographic Late Lumen Loss measures"
How many subjects are participating in this experiment?
"Affirmative, a review of the clinicaltrials.gov data indicates that this medical investigation is currently seeking participants. The study was first advertised on August 17th 2021 and revised as recently as May 12th 2022. In total, 30 patients must be enrolled between 3 different sites."
What are the qualifications for taking part in this research program?
"This medical trial is open to 30 individuals aged 18-90 that suffer from peripheral arterial disease and meet a list of additional requirements. Patients must provide written consent, have a claudication or chronic limb threatening ischemia diagnosis, commit to attending follow up visits and angiograms, possess suitable vascular access in their common femoral artery (no radial or pedal entry points), display native infrapopliteal lesions with over 70% stenosis when viewed on an angiogram, the reference vessel diameter must be between 2.5 - 3.5 mm by IVUS imaging; no more than three 18mm scaffolds or one"
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