Critical Limb Ischemia
Conditions
Brief summary
The purpose of this trial is to evaluate the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA. The Drug Eluting Temporary Spur Stent System is intended for use as a primary treatment in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.
Detailed description
This is a randomized controlled trial evaluating the safety and efficacy of the Drug Eluting Temporary Spur Stent System (Spur) compared to percutaneous transluminal balloon angioplasty (PTA). The trial will be conducted in two phases. Phase A is a prospective, multi-center, 1:1 randomized dual arm study of 20 subjects, evaluating the short-term safety of the Drug Eluting Temporary Spur Stent System compared to PTA to treat lesions in infrapopliteal arteries in subjects with critical limb ischemia (CLI). Thirty (30) day data from Subjects in Phase A will be evaluated by an independent Data Safety Monitoring Board (DSMB) and submitted to the Food and Drug Administration (FDA) for review. Phase A subjects will be rolled into Phase B. Phase B is a prospective, multicenter, 1:1 randomized dual arm study of no less than 345 and up to 518 subjects, evaluating the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA to treat lesions in infrapopliteal arteries in subjects with CLI.
Interventions
DEVICEDrug Eluting Temporary Spur Stent System
The Spur Stent consists of a sirolimus coated stent and balloon that is retrievable after delivery of the sirolimus formulation.
DEVICEPercutaneous Transluminal Balloon Angioplasty
A balloon catheter is inserted across a lesion and inflated to fracture and compress the plaque, creating a larger lumen and improved blood flow through the artery.
Sponsors
ReFlow Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subject will be blinded from their treatment assignment through the 12-month follow-up visit.
Intervention model description
Phase A will enroll 20 subjects and evaluate 30-day safety data Phase B will enroll 345 to 518 subjects. Subjects from Phase A will be rolled into Phase B.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pre-Procedure Inclusion Criteria: 1. Subject willing and able to provide informed consent and able to comply with the study protocol and follow up. Subjects who are unable to sign due to a physical limitation may have a Legally Authorized Representative (LAR), including a family member, sign on their behalf. 2. Life expectancy greater than 1 year in the investigator's opinion. 3. Subject is greater than 18 years of age. 4. Subjects must have chronic (greater than 14 days) symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 4-5, rest pain (R4), and/or minor tissue loss (R5), that in the opinion of the investigator are not amenable to conservative medical therapy and require endovascular intervention for alleviation of symptoms and tissue preservation. 5. For subjects with bilateral disease, planned treatment of the contralateral limb must either be performed greater than or equal to 7 days prior to the index procedure or greater than or equal to 30 days following the index procedure. Angiographic Inclusion Criteria: 1. Stenotic, restenotic, or occlusive lesions with greater than or equal to 70% stenosis located in the infrapopliteal vessels, with target lesion that can be successfully crossed with a guidewire via the true lumen. 2. Iliac, Superficial Femoral Artery (SFA) and popliteal inflow lesions can be treated using standard of care during the index procedure Note: 1. Inflow lesions treated intraprocedure must be treated first, prior to consideration of treatment of infrapopliteal lesions. 2. Treatment of in-stent restenosis in inflow treatment is permitted, provided that stents are not severely fractured or otherwise compromised. 3. Distal embolic protection is strongly encouraged in cases where atherectomy is used. 4. Inflow lesions must have a healthy vessel segment of greater than 30 mm between the study lesion and the treated segment, defined as less than 50% stenosis without aneurysmal segments. 5. Inflow treatment must be successful, prior to treatment of the target lesion, resulting in stenosis less than or equal to 30%, without resulting flow limiting (Type D or greater) dissection, thrombus, or aneurysm by angiography prior to randomization. 3. Target vessel reconstitutes at or above the ankle, with the target treated segment ending at least 10 mm above the ankle joint. Note: 1. If the anterior tibial or posterior tibial arteries are treated, there must be inline flow to the foot. 2. If the peroneal artery is treated, there must be at least one collateral supplying the foot. 3. In all cases, patent runoff (no lesions with greater than 50% stenosis) must be present via the dorsalis pedis and/or plantar arteries. 4. Target lesion must be located in the tibial arteries. If vessel sizing remains appropriate, treatment may extend into the distal popliteal (P3) segment. 5. Target vessel reference diameter is measured to be greater than or equal to 2.5 and less than or equal to 4.25 mm in diameter assessed by one of the following methods after successful completion of guidewire crossing of the lesion site (visual estimate permitted): 1. Intravascular Ultrasound (IVUS) 2. Quantitative Vascular Angiography (QVA) 3. Visual Estimate 6. Target lesion length must be less than or equal to 210 mm cumulatively. Tandem lesions that are less than or equal to 4 cm should be treated as one lesion. Multiple discrete lesions may be treated provided cumulative length is less than or equal to 210 mm. 7. Only one limb and one vessel may be enrolled per subject. If the investigator feels that multiple infrapopliteal vessels must be treated during the index procedure, a standard practice treatment may be performed in the non-target infrapopliteal vessel(s). This should be prior to randomization of and treatment of the target vessel whenever possible. Note: 1. Distal embolic protection is strongly recommended in cases using atherectomy. 2. Treatment of the target vessel/lesion may be performed only if treatment of the non-target vessel(s)/lesion(s) does not result in a complication which may compromise the outflow of the target lesion or result in a major adverse limb event. 3. Treatment of non-target lesions must be parallel to, and not contiguous with, the target lesion. 8. Retrograde access (in the infrapopliteal arteries) is permitted for lesion crossing; however, the randomized treatment must be deployed from antegrade (above the knee, either ipsilateral or contralateral) access.
Exclusion criteria
Pre-procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase A: Primary Safety Endpoint | 30 Days | Freedom from the occurrence of major adverse limb events (MALE), and peri-operative death (POD), in Drug Eluting Temporary Spur Stent System and PTA-treated subjects through 30 days post-procedure. MALE are defined as: * Major amputation above the ankle * Major (open vascular surgery) reintervention * Target vessel thrombectomy or thrombolysis |
| Phase B: Primary Safety Endpoint | 30 Days & 6 Months | Freedom from the occurrence of POD at 30 days, and the occurrence of MALE at 6 months. |
| Phase B: Primary Efficacy Endpoint | 6 Months | Freedom from a composite endpoint of the occurrence of limb salvage and primary patency events at 6 months, defined as: * Clinically-driven target lesion revascularization (CD-TLR). * Above the ankle amputation in the index limb, in the presence of a totally occluded target vessel. * 100% total occlusion of target lesion in Spur and PTA-treated subjects. |
Contacts
Primary ContactCarolyn Mascho, BSN, DNP, AG-NP
Outcome results
None listed