REsorbable SCaffolds With everolimUs-Elution for the Treatment of Infrapopliteal Artery Disease in Patients With Chronic Limb-threatening Ischemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott.
- Who it may be relevant to
- Registry conditions: Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott
The 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.
Primary outcome measures
- Number of lesions free from Clinically-Driven Target Lesion Revascularization (CD-TLR) [Time frame: 12 months]
Secondary outcome measures (12)
- CD-TLR-free survival per target lesion [Time frame: Until the end of the follow-up period of 3 years]
- Clinical response using Rutherford classification categories [Time frame: 12, 24, and 36 months]
- Wound status [Time frame: 12, 24, and 36 months]
- Freedom from major amputation of the target limb [Time frame: 12 and 24 months]
- Amputation-free survival [Time frame: Until the end of the follow-up period of 3 years]
- Overall survival [Time frame: Until the end of the follow-up period of 3 years]
- Patient-reported health-related quality-of-life [Time frame: Baseline, Day 0 (day of procedure), 6-, 12-, 24-, 26-months post treatment]
- Frequency and severity of procedural complications and other adverse events [Time frame: Within 30 days after the index procedure]
- Frequency of major adverse limb events (MALE) and peri-operative death (POD). [Time frame: 6 months for MALE; Within 30 days after the index procedure for POD]
- Clinical response using ankle-brachial index (ABI) [Time frame: 12, 24, and 36 months]
- Clinical response using toe pressure [Time frame: 12, 24, and 36 months]
- Clinical response using WIfi (wound, ischemia and foot infection) score [Time frame: 12, 24, and 36 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- Patients planned to receive an above ankle amputation of the target limb;
- Patients enrolled in ORACLE (ClinicalTrials.gov ID NCT07270562).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Filippiadis DK, Binkert C, Pellerin O, Hoffmann RT, Krajina A, Pereira PL. Cirse Quality Assurance Document and Standards for Classification of Complications: The Cirse Classification System. Cardiovasc Intervent Radiol. 2017 Aug;40(8):1141-1146. doi: 10.1007/s00270-017-1703-4. Epub 2017 Jun 5. PMID 28584945
Identifiers
NCT: NCT07270575 · RESCUE