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Augmenting ischemia-induced vasculo- and angiogenesis after endovascular reperfusion with host-extracted, percutaneously introduced, leucocyte- and platelet-rich fibrin in patients with critical limb ischemia

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518657-42-00
Acronym
ARISTOTLE
Enrollment
100
Registered
2025-01-28
Start date
2024-12-17
Completion date
Unknown
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

critical limb ischemia

Brief summary

Primary endpoint: the type and frequency of adverse reactions and events assessed during the study and at the final visit.

Detailed description

Secondary endpoints: mortality rate at the final visit, amputation rate at the final visit, time to revascularization (continuous assessment), amputation-free survival time (continuous assessment), muscle perfusion in imaging studies (at the final visit compared to baseline), ankle-brachial index (at the final visit compared to baseline), change in ischemia scores (Rutherford, WiFI) (at the final visit compared to baseline), and quality of life score at the final visit.

Interventions

DRUGLeukocyte-Platelet Rich Fibrin

Sponsors

Medical University Of Warsaw
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Primary endpoint: the type and frequency of adverse reactions and events assessed during the study and at the final visit.

Secondary

MeasureTime frame
Secondary endpoints: mortality rate at the final visit, amputation rate at the final visit, time to revascularization (continuous assessment), amputation-free survival time (continuous assessment), muscle perfusion in imaging studies (at the final visit compared to baseline), ankle-brachial index (at the final visit compared to baseline), change in ischemia scores (Rutherford, WiFI) (at the final visit compared to baseline), and quality of life score at the final visit.

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026