RESCUE is a Europe-wide study that will follow 400 people with critical limb-threatening ischemia (CLTI). It aims to see how well Esprit BTK™ Everolimus Eluting Resorbable Scaffolds work in real-life medical settings. The study focuses on people who have heavily calcified arteries in the infrapopliteal areas of the leg.
These drug-eluting resorbable scaffolds release a medication that helps prevent the inner wall of the blood vessel from thickening after injury or surgery. This can reduce the chance of the artery becoming blocked again (a problem called restenosis), while also giving temporary structural support to the vessel. Over time, the scaffold naturally dissolves in the body, which may lower the long-term risks associated with permanent metal stents.
Rutherford classification category ≥4;
Treatment of infrapopliteal lesions with the Esprit BTK everolimus eluting resorbable scaffold system following adequate vessel preparation;
Calcification of target lesions must be visible on fluoroscopy or CT-angiography;
Patients competent and willing to provide informed consent.
Minors and other vulnerable populations who may not be able to give informed consent freely or for whom participation is not essential to the study (incapacitated and unconscious individuals, persons deprived of liberty, pregnant and breastfeeding women, etc.);
Inadequate inflow (>30% stenosis) following optimization;
Insufficient direct outflow (less than 1 run-off vessel);
Endovascular procedure(s) on the treatment site within 4 weeks before index procedure;
Adult CLTI patients treated with the Esprit BTK everolimus-eluting resorbable scaffold following adequate vessel preparation for infrapopliteal artery disease.
Cohort
Prospective
Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott
DeviceThe Esprit BTK™ is a bioresorbable vascular scaffold designed for arteries below the knee. It provides temporary support to keep the vessel open while releasing everolimus-an antiproliferative drug that helps prevent excessive tissue growth and reduces the risk of restenosis. As the scaffold delivers the medication, it gradually dissolves, potentially lowering long-term risks associated with permanent stents.
Number of lesions free from Clinically-Driven Target Lesion Revascularization (CD-TLR)
Defined as freedom from any endovascular re-intervention to the target lesion (± 10 mm) or surgical bypass performed because of restenosis or occlusion of the target lesion.
CD-TLR-free survival per target lesion
Defined as the time between first index procedure and any endovascular re-intervention to the target lesion (± 10 mm) or surgical bypass performed because of restenosis or occlusion of the target lesion.
Clinical response using Rutherford classification categories
The Rutherford classification is a clinical scale used to categorize the severity of peripheral arterial disease: Category 0 = asymptomatic; Category 1 = mild claudication; Category 2 = moderate claudication; Category 3 = severe claudication; Category 4 = ischemic rest pain; Category 5 = minor tissue loss; Category 6 = severe tissue loss.
Wound status
Defined as healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening).
Freedom from major amputation of the target limb
Defined as absence of any amputation of the target limb (above ankle).
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