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COMPLETED

SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients

NCT03452293 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 92 participants
Start Date 2018-03-07
Est. Completion 2022-03-28

Sponsor

EndoCore Lab s.r.l.

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03452293

The ClinicalTrials.gov registry entry for NCT03452293 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EndoCore Lab s.r.l., which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03452293 reports 15 study locations spanning 14 distinct geographic areas — top geographies include RM, Michigan, Santa Fe Province. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03452293?

The interventions under investigation include: Stent Peripheral System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

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. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial