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NCT03452293 · ClinicalTrials.gov registry record
SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients
A clinical trial of PAD, sponsored by EndoCore Lab s.r.l..
- Completed
- Registry status
- 92
- Enrollment target
- 15
- Study locations
NCT03452293: Completed study of PAD, sponsored by EndoCore Lab s.r.l..
NCT03452293 is a study of PAD that has completed, run by EndoCore Lab s.r.l.. The registered enrollment target is 92 participants, below the 138-participant average among 3 other PAD trials with a reported enrollment target (33% lower). The trial reports 15 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03452293, a study of PAD, has completed, sponsored by EndoCore Lab s.r.l..
- COMPLETED
- Registry status
- 92 participants
- Enrollment target
- 15
- Study locations
Study Summary
The study will evaluate the safety and efficacy of subintimal Supera stenting in complex de novo or re-occlusive CTO (TASC C-D) lesions in patients with CLI. This study will be performed based on a rigorous sample size calculation, which will allow us to have the statistical power to validate our conclusions and therefore establish the generalizability of this strategy.
Primary Outcome
Primary Patency is defined as freedom from clinically driven TLR (CD-TLR) defined as repeat percutaneous intervention or surgical bypass graft to treat an angiographic significant restenosis (\>50%) at the level of the treated lesion ±10 mm (proximally and/or distally)
Conditions Studied
Interventions
- DEVICE Stent Peripheral System
Study Locations (15)
RM
- Policlinico Tor Vergata - Roma
- A.O. San Giovanni Addolorata - Roma
Michigan
- Metro Health Hospital - Wyoming
Santa Fe Province
- Instituto Medico CENICLAR, Unidad Sanatorio de la Mujer - Rosario
AQ
- Ospedale di Avezzano - Avezzano
CE
- Clinica San Michele - Maddaloni
CT
- A.O.U. Policlinico Vittorio Emanuele - Catania
LE
- A.O. Cardinale Panico - Tricase
Padova
- Casa di Cura Abano Terme - Abano Terme
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2018-03-07 |
| Est. Completion | 2022-03-28 |
What the finished NCT03452293 record still lists
NCT03452293 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 138-participant average among 3 other PAD trials with a reported enrollment target (33% lower).
The record links to 1 condition, with PAD appearing as the primary indexed condition, and to 1 intervention - of which Stent Peripheral System is the first listed.
NCT03452293 lists 15 locations in 14 states (RM, Michigan, Santa Fe Province).
Frequently Asked Questions
What is clinical trial NCT03452293 about?
NCT03452293 is a clinical study titled "SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients". The study will evaluate the safety and efficacy of subintimal Supera stenting in complex de novo or re-occlusive CTO (TASC C-D) lesions in patients with CLI. This study will be performed based on a rigorous sample size calculation, which will allow us to have the statistical power to validate our co...
What is the current status of trial NCT03452293?
This trial is currently completed. The enrollment target is 92 participants. The study started on 2018-03-07. Estimated completion is 2022-03-28.
What conditions does trial NCT03452293 study?
This clinical trial studies the following conditions: PAD.
What interventions are being tested in trial NCT03452293?
The interventions under investigation include: Stent Peripheral System (DEVICE).
Who is sponsoring clinical trial NCT03452293?
This trial is sponsored by EndoCore Lab s.r.l., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03452293 being conducted?
This trial has 15 study locations across Michigan, Santa Fe Province, AQ, CE, CT. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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