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New treatment option for Critical Limb-Threatening Ischemia
Official title Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in the Treatment of Patients With Below the Knee Disease in Australia
ClinicalTrials.gov ID: NCT06075940
What this study is testing
- What it's testing
- The objective of this prospective, multi-center, clinical investigation is to evaluate the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Up to 30 subjects will be enrolled at approximately 3 clinical sites in Australia.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 7.1.1 General 1. Subject (or their legally authorized representative) has provided written informed consent prior to any study-related procedure...
- 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...
- Subject has symptomatic chronic limb-threatening ischemia, determined as Rutherford categories 4 or 5.
- Subject is ≥ 18 years and ≤ 90 years of age.
- Subject agrees to complete all protocol-required follow-up visits, including angiograms. 7.1.2 Angiographic 6. Target lesion(s) in the infrapopliteal...
You likely can't join if
- 7.2.1 General Exclusion Criteria people must not meet any of the following general and angiographic exclusion criteria:
- Subject with Body Mass Index (BMI) \< 18.
- Subject is pregnant or nursing. people who plan pregnancy during the clinical investigation follow-up period may not be enrolled. Note: people of...
- Estimated life expectancy \<1 year, in the opinion of the Investigator at the time of enrollment.
- Subject is permanently bedridden.
- Subject has known hypersensitivity or contraindication to device materials and their degradants (sirolimus, poly (L-lactide), poly (D, L-lactide)...
See the full eligibility criteria
Who can join
- 7.1.1 General 1. Subject (or their legally authorized representative) has provided written informed consent prior to any study-related procedure, using the form approved by the Human Research Ethics Committee.
- 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...
- Subject has symptomatic chronic limb-threatening ischemia, determined as Rutherford categories 4 or 5.
- Subject is ≥ 18 years and ≤ 90 years of age.
- Subject agrees to complete all protocol-required follow-up visits, including angiograms. 7.1.2 Angiographic 6. Target lesion(s) in the infrapopliteal vessel(s) of the same limb located in any of the following vessels...
- 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.
- Up to two (2) target lesions and two different arteries can be treated, where all target lesions must be successfully crossed with a guidewire prior to randomization. Note: For CTO, retrograde crossing of the lesion is...
- 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...
- Inflow above-the-knee lesions must be treated successfully (\ 50% stenosis) in the P3 segment of the popliteal artery (infrageniculate) is an exclusion criterion. Note: Inflow lesions may be treated during the index...
- Target lesion must have reference vessel diameter is between 3.0 - 3.5 mm by angiography. Vessel size measured by IVUS is highly recommended to verify RVD.
- Target lesion(s) is de novo or restenosed ≥ 70% stenosed by angiography. Note: In-stent restenosis is an exclusion criterion.
- The total target lesion length among all target lesions must not exceed 11 cm.
- Minimum target lesion length must be \>14 mm.
- Total scaffold length must not exceed 12 cm, and include at least 2 mm of normal vessel from each pre-dilatation border.
- The target vessel must not have any other angiographic significant non-target lesions (≥ 50%).
- 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.
- 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).
- 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...
- 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).
- 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...
What rules you out
- 7.2.1 General Exclusion Criteria people must not meet any of the following general and angiographic exclusion criteria:
- Subject with Body Mass Index (BMI) \< 18.
- Subject is pregnant or nursing. people who plan pregnancy during the clinical investigation follow-up period may not be enrolled. Note: people of child-bearing potential must have a negative pregnancy test ≤ 28 days...
- Estimated life expectancy \<1 year, in the opinion of the Investigator at the time of enrollment.
- Subject is permanently bedridden.
- Subject has known hypersensitivity or contraindication to device materials and their degradants (sirolimus, poly (L-lactide), poly (D, L-lactide), lactic acid, or platinum-iridium) or to study medications (including...
- Subject has planned surgery or procedure necessitating discontinuation of antiplatelet medications within 6 months after the index procedure.
- Subject has had revascularization procedure within the target vessel in the previous 3 months
- Subject has prior major amputation involving the target limb. Note: Major amputation of the contralateral limb is allowed.
- Subject has planned surgical or endovascular procedure within 6 months following the index procedure. Note: A planned minor amputation (toe and/or transmetatarsal amputation in either limb) is allowed. Treatment of...
- Subject who has severe ischemia (ABI ≥ 0.39).
- Subject who has neuropathic lesion(s) with no ischemic component (wounds or ulcers occur on pressure zones of the foot with or without Type 2 diabetes , deformed foot/toes, hematoma, edema ).
- Subject has presence of osteomyelitis or any gangrene above the metatarsal-phalangeal joints, extensive tissue loss with exposed tendons or requiring complex or recurrent surgeries, full thickness heel ulcer, or pure...
- Subject with uncontrolled diabetes with HbA1c \> 10%.
- Subject has a prior stroke or myocardial infarction within 3 months of the index procedure.
- Subject has acute renal failure, severe or end-stage chronic kidney disease (eGFR \< 30 mL/min) or requires dialysis.
- Subject has active systemic infection.
- Subject is receiving immunosuppression therapy and/or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, severe asthma requiring...
- Subject has active malignancy (receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the index procedure), active blood dyscrasia or coagulation disorder (platelet count \...
- Subject is an incapacitated individual, defined as a person who is mentally ill, mentally handicapped, or an individual without legal authority to control their activities.
- Subject has significant comorbid condition(s), or other medical, social, or psychological conditions (such as history of substance abuse, e.g., alcohol, cocaine, heroin, etc.), that in the Investigator's opinion may...
- Angiographic evidence of thromboembolism or atheroembolism in the target or non-target vessel as confirmed by angiography.
- Non target lesion located in the popliteal P3 (infrageniculate) segment or treated with atherectomy.
- Presence of aneurysm or acute thrombus in the aorta or lower extremity arteries.
- Prior below-the-knee bypass in the target limb.
- Previously stented lesion(s) or the presence of stents in the target vessel.
- Target vessel(s) have distal hemodynamically significant lesions (≥ 50% diameter stenosis by angiography) outside of the allowed treatment zone (presence of non-target lesions in the target vessel is an exclusion...
- Lesions (target or non-target) with severe calcification (per PACSS 4 classification).
- Unsuccessful treatment of stenosis (≥ 50% stenosis) of in-flow arteries.
- Absence of a patent pedal artery. Absence of contiguous dorsalis pedis or common plantar arteries if the target vessels are anterior or posterior tibial arteries, respectively.
- Target lesion location requires bifurcation treatment with scaffolding of both branches (kissing scaffold is not allowed). In case of presence of disease at a bifurcation, one vessel can be treated as target and the...
- Lesions (target or non-target) in which successful predilatation cannot be achieved.
- Planned atherectomy treatment of any target or non-target lesion.
The study team makes the final eligibility decision.
Where it's taking place
- Randwick, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Randwick, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.