SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients
NCT ID: NCT03452293
Last Updated: 2022-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
92 participants
OBSERVATIONAL
2018-03-07
2022-03-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intra-patient Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT (Optical Coherence Tomography) Follow up
NCT02785237
Italian Absorb Registry
NCT02298413
Self-apposing Stentys Stents Registry
NCT02784405
International Randomized Comparison Between DES Limus Carbostent and Taxus DES in the Treatment of De-novo Coronary Lesions
NCT01373502
Optical Coherence TomOgraphy Assessment of the Drug-Eluting Stent
NCT01012583
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done.
Patients elected for endovascular revascularization with SuperSub strategy will be asked their written consent to the use of their personal data.
Revascularization will be performed as per standard procedure of the sites. After discharge all patients will attend clinic visits at 30 days (±14 days), 6 months (±30 days), 12 months (±30 days) and 24 months (±30 days). Angiographic follow-up will be performed only in symptomatic patients, as clinically indicated and with the aim for a new treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stent Peripheral System
Peripheral PTA with Supera Stent implantation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥18 years
* Patient has signed an approved consent form
* Patients without previous stenting of the Fem-Pop segment
* Patent and hemodynamically normal iliac and common femoral arteries.
* At least one patent and healthy tibial vessel runoff to the foot.
* Patient has documented TASC C or D Fem-Pop CTO's prior to the study procedure
* Rutherford Category 4, 5 or 6
* Subintimal crossing of the occluded Fem-Pop vessels
* Supera Stenting From healthy to healthy arterial segment.
Exclusion Criteria
* Endoluminal crossing of the CTO
* Inability to stent from "healthy to healthy" arterial segments.
* Inability to re-enter within the pre-specified Ideal Landing Zone (IDL)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione Italiana Vascolare
OTHER
EndoCore Lab s.r.l.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maria Salomone, MD
Role: STUDY_DIRECTOR
EndoCore Lab
Mariano L Palena, MD
Role: STUDY_CHAIR
Casa di Cura Abano Terme
Larry J Diaz, MD,PhD
Role: STUDY_CHAIR
Metro Health Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Metro Health Hospital
Wyoming, Michigan, United States
Instituto Medico CENICLAR, Unidad Sanatorio de la Mujer
Rosario, Santa Fe Province, Argentina
Ospedale di Avezzano
Avezzano, AQ, Italy
Clinica San Michele
Maddaloni, CE, Italy
A.O.U. Policlinico Vittorio Emanuele
Catania, CT, Italy
A.O. Cardinale Panico
Tricase, LE, Italy
Casa di Cura Abano Terme
Abano Terme, Padova, Italy
A.O.U. Santa Maria della Misericordia
Perugia, PG, Italy
Policlinico Tor Vergata
Roma, RM, Italy
A.O. San Giovanni Addolorata
Roma, RM, Italy
A.O.U. di Sassari
Sassari, SS, Italy
Ospedale San Antonio Abate
Erice, TP, Italy
Azienda Ospedaliera Santa Maria di Terni
Terni, TR, Italy
AORN Antonio Cardarelli
Napoli, , Italy
London North West HealthCare NHS Trust
London, England, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EndoCore01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.