Contacts

Claire Poulet, PhD

CONTACT

+41 79 385 16 78 [email protected]

Dhwani S. Korde, PhD

CONTACT

+4367762942469 [email protected]

Sponsors

Lead Sponsor

Cardiovascular and Interventional Radiological Society of Europe

Collaborators

Abbott

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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).

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What this study is about

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Contacts

Sponsors

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Trial snapshot

Condition

For caregivers