NCT03452293

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
4 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

March 7, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2022

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

4.1 years

First QC Date

February 14, 2018

Last Update Submit

October 31, 2022

Conditions

PAD

Outcome Measures

Primary Outcomes (1)

  • Primary Patency Rate

    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)

    24 months

Secondary Outcomes (19)

  • Freedom from Restenosis

    12 months

  • Freedom from Restenosis

    24 months

  • Composite of All Major Adverse Events

    12 Months

  • Composite of All Major Adverse Events

    24 Months

  • Incidence of Major Adverse Events

    12 months

  • +14 more secondary outcomes

Other Outcomes (6)

  • Cost-efficiency analysis

    12 months

  • Cost-efficiency analysis

    24 months

  • Technical success

    1 month

  • +3 more other outcomes

Interventions

Stent Peripheral SystemDEVICE

Peripheral PTA with Supera Stent implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients affected by lower extremities artery disease and referred for the endovascular treatment of de novo or re-stenotic lesions (no in stent restenosis) in the femoro-popliteal arteries.

You may qualify if:

  • Patients with CLI and TASC C-D Fem-Pop CTO's
  • 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.

You may not qualify if:

  • Patient unwilling or unlikely to comply with Follow-Up schedule
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

Instituto Medico CENICLAR, Unidad Sanatorio de la Mujer

Rosario, Santa Fe Province, S2000, Argentina

Location

Ospedale di Avezzano

Avezzano, AQ, 67051, Italy

Location

Clinica San Michele

Maddaloni, CE, 81024, Italy

Location

A.O.U. Policlinico Vittorio Emanuele

Catania, CT, 95123, Italy

Location

A.O. Cardinale Panico

Tricase, LE, 73039, Italy

Location

Casa di Cura Abano Terme

Abano Terme, Padova, 35031, Italy

Location

A.O.U. Santa Maria della Misericordia

Perugia, PG, 06129, Italy

Location

Policlinico Tor Vergata

Roma, RM, 00133, Italy

Location

A.O. San Giovanni Addolorata

Roma, RM, 00184, Italy

Location

A.O.U. di Sassari

Sassari, SS, 07100, Italy

Location

Ospedale San Antonio Abate

Erice, TP, 91016, Italy

Location

Azienda Ospedaliera Santa Maria di Terni

Terni, TR, 05100, Italy

Location

AORN Antonio Cardarelli

Napoli, 80131, Italy

Location

London North West HealthCare NHS Trust

London, England, HA1 3UJ, United Kingdom

Location

Study Officials

  • Maria Salomone, MD

    EndoCore Lab

    STUDY DIRECTOR

  • Mariano L Palena, MD

    Casa di Cura Abano Terme

    STUDY CHAIR

  • Larry J Diaz, MD,PhD

    Metro Health Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2018

First Posted

March 2, 2018

Study Start

March 7, 2018

Primary Completion

March 28, 2022

Study Completion

March 28, 2022

Last Updated

November 2, 2022

Record last verified: 2022-10

Locations

IT(12)US(1)AR(1)GB(1)