Esprit BTK everolimus-eluting resorbable scaffold in infrapopliteal artery disease for CLTI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

RESCUE is a Europe-wide observational study enrolling about 400 adults with chronic limb-threatening ischemia to see how the Esprit BTK everolimus-eluting resorbable scaffold performs in routine care. Participants have calcified infrapopliteal lesions and undergo scaffold implantation after proper vessel preparation. The study will track safety and effectiveness measures over time as the scaffold gradually dissolves, potentially reducing restenosis risk and avoiding long-term metal stents. Data will come from real-world clinical settings across multiple centers. Primary insights will come from observational follow-up rather than a randomized comparison.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Rutherford classification category ≥4;
2. Treatment of infrapopliteal lesions with the Esprit BTK everolimus eluting resorbable scaffold system following adequate vessel preparation;
3. Calcification of target lesions must be visible on fluoroscopy or CT-angiography;
4. Patients competent and willing to provide informed consent.

Exclusion Criteria:

1. 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.);
2. Inadequate inflow (\>30% stenosis) following optimization;
3. Insufficient direct outflow (less than 1 run-off vessel);
4. Endovascular procedure(s) on the treatment site within 4 weeks before index procedure;
5. Patients planned to receive an above ankle amputation of the target limb;
6. Patients enrolled in ORACLE (ClinicalTrials.gov ID NCT07270562).

Where it's running

• Hull University Teaching Hospitals NHS Trust
  Hull, United Kingdom Recruiting

Study contacts

• Study coordinator: Claire Poulet, PhD
• Email: oracue@cirse.org
• Phone: +41 79 385 16 78

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.