NCT06416644

Brief Summary

The SupPORT Registry aims at collecting real-world from Portuguese centers performing femoral-popliteal revascularization with Supera (r) implants. This is a prospective non-randomized non-controlled consecutive registry.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

15 active sites

Status
active not recruiting

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

Study Progress83%
Apr 2023Dec 2026

Study Start

First participant enrolled

April 1, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

3.8 years

First QC Date

April 30, 2024

Last Update Submit

August 20, 2025

Conditions

Lower Limb IschemiaPeripheral Arterial DiseaseChronic Limb-Threatening IschemiaChronic Limb IschemiaAtherosclerosis of Femoral ArterySuperficial Femoral Artery StenosisSuperficial Femoral Artery OcclusionSuperficial Femoral Artery DiseaseSuperficial Femoral Artery LesionsPopliteal Artery OcclusionPopliteal Artery StenosisPopliteal Arterial Stenosis

Keywords

SuperaVasculomimeticStentChronic limb-threatening ischemiaChronic limb ischemiaSuperficial femoral arterypopliteal artery

Outcome Measures

Primary Outcomes (3)

  • Freedom from major limb amputation

    Number of limbs surviving without above ankle amputation

    1 year

  • Target Lesion Revascularization (TLR)

    Number of target lesions requiring re-intervention

    1 year

  • MALE - Major Adverse Limb Event

    Composite endpoint Major Amputation, any index limb revascularization

    1 year

Secondary Outcomes (6)

  • MACE - Major Adverse Cardiovascular Event

    1 year

  • All-cause Death

    1 year

  • Cardiovascular-related death

    1 year

  • Primary Patency, Primary Assisted Patency, Secondary Potency

    1 year

  • Ankle-Brachial Index

    1 year

  • +1 more secondary outcomes

Study Arms (1)

Supera implant

EXPERIMENTAL

Supera implant

Device: Supera Vasculomimetic Stent

Interventions

Supera Vasculomimetic StentDEVICE

Femoral-popliteal revascularization with Supera Stent

Supera implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Evidence of symptomatic obstructive peripheral arterial disease.
  • All-comer patients undergoing endovascular lower-limb revascularization with Supera® stent implantation in the superficial femoral (SFA) or popliteal arteries.
  • Patient or legal representative understand the SupPORT registry procedures, and have voluntarily provided informed written consent regarding their participation.
  • Participant is willing to remain in the SupPORT Registry for at least 1 year.
  • Target lesion is a primary atherosclerotic lesion or a restenosis occurring in a non-stented of the SFA or the popliteal artery, distancing at least ≥ 1 cm from any previously implanted vascular stent.
  • Target lesion causes a ≥50% arterial obstruction (visually confirmed on digital subtraction angiography).

You may not qualify if:

  • Any contraindication for peri-interventional or post-interventional anti-thrombotic therapy (including, but not restricted to Non-fractioned heparina, low-molecular weight heparina \[LMWH\], Clopidogrel, Ticagrelol, Ticlopidine, Acetylsalicylic acid, dipiridamol, direct thrombin \[factor II\] or factor Xa inhibitors, vitamin-K antagonists).
  • Participation in other research study that may influence obtained results.
  • Pregnant or breastfeeding women, or expected pregnancy to occur during the study period.
  • Treatment of intrastent restenosis/occlusion of previous peripheral vascular stent.
  • Non-corrected hemodynamically significant obstructive arterial disease of the ipsilateral inflow arteries (aorta, iliac arteries)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Hospital de Faro - Centro Hospitalar do Algarve

Faro, Algarve, 8000, Portugal

Location

Hospital Divino Espírito Santo

Ponta Delgada, Azores, 9500, Portugal

Location

Hospital Garcia de Orta

Almada, Lisbon District, Portugal

Location

Centro Hospitalar Tâmega e Sousa

Penafiel, Porto District, 4564, Portugal

Location

Centro Hospitalar Vila Nova de Gaia e Espinho

Vila Nova de Gaia, Porto District, 4430, Portugal

Location

Hospital Santo Espírito Ilha Terceira

Angra do Heroísmo, Terceira, 9700, Portugal

Location

Centro Hospitalar Universitário de Coimbra

Coimbra, 3004, Portugal

Location

Hospital da Senhora da Oliveira de Guimarães

Guimarães, 4835, Portugal

Location

Hospital de Santa Marta - Centro Hospitalar Lisboa Central

Lisbon, 1169, Portugal

Location

Hospital Egas Moniz - Centro Hospitalar Lisboa Central

Lisbon, 1349, Portugal

Location

Hospital de Santa Maria - Centro Hospitalar Lisboa Norte

Lisbon, 1649, Portugal

Location

Centro Hospitalar Universitário de Santo António

Porto, 4099, Portugal

Location

Centro Hospitalar São João

Porto, 4202, Portugal

Location

Centro Hospitalar de Trás-os-Montes e Alto Douro

Vila Real, 5000, Portugal

Location

Centro Hospitalar Tondela Viseu

Viseu, 3504, Portugal

Location

Related Publications (5)

  • Gao M, Hua Y, Zhao X, Jia L, Yang J, Liu B. Optimal Ultrasound Criteria for Grading Stenosis of the Superficial Femoral Artery. Ultrasound Med Biol. 2018 Feb;44(2):350-358. doi: 10.1016/j.ultrasmedbio.2017.10.001. Epub 2017 Nov 14.

    PMID: 29150366BACKGROUND

  • Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10.

    PMID: 30586774BACKGROUND

  • Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.

    PMID: 24126108BACKGROUND

  • Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH, Aboyans V, Aksoy M, Alexandrescu VA, Armstrong D, Azuma N, Belch J, Bergoeing M, Bjorck M, Chakfe N, Cheng S, Dawson J, Debus ES, Dueck A, Duval S, Eckstein HH, Ferraresi R, Gambhir R, Gargiulo M, Geraghty P, Goode S, Gray B, Guo W, Gupta PC, Hinchliffe R, Jetty P, Komori K, Lavery L, Liang W, Lookstein R, Menard M, Misra S, Miyata T, Moneta G, Munoa Prado JA, Munoz A, Paolini JE, Patel M, Pomposelli F, Powell R, Robless P, Rogers L, Schanzer A, Schneider P, Taylor S, De Ceniga MV, Veller M, Vermassen F, Wang J, Wang S; GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. 2019 Jul;58(1S):S1-S109.e33. doi: 10.1016/j.ejvs.2019.05.006. Epub 2019 Jun 8.

    PMID: 31182334BACKGROUND

  • Rocha-Singh KJ, Zeller T, Jaff MR. Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv. 2014 May 1;83(6):E212-20. doi: 10.1002/ccd.25387. Epub 2014 Feb 10.

    PMID: 24402839BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial DiseaseChronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2024

First Posted

May 16, 2024

Study Start

April 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

PT(15)