Peripheral Arterial Disease Clinical Trial
— SupPORT registOfficial title:
The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - • 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) |
Country | Name | City | State |
---|---|---|---|
Portugal | Hospital Garcia de Orta | Almada | Lisboa |
Portugal | Hospital Santo Espírito Ilha Terceira | Angra do Heroísmo | Terceira |
Portugal | Centro Hospitalar Universitário de Coimbra | Coimbra | |
Portugal | Hospital de Faro - Centro Hospitalar do Algarve | Faro | Algarve |
Portugal | Hospital da Senhora da Oliveira de Guimarães | Guimarães | |
Portugal | Hospital de Santa Maria - Centro Hospitalar Lisboa Norte | Lisboa | |
Portugal | Hospital de Santa Marta - Centro Hospitalar Lisboa Central | Lisboa | |
Portugal | Hospital Egas Moniz - Centro Hospitalar Lisboa Central | Lisboa | |
Portugal | Centro Hospitalar Tâmega e Sousa | Penafiel | Porto |
Portugal | Hospital Divino Espírito Santo | Ponta Delgada | Azores |
Portugal | Centro Hospitalar São João | Porto | |
Portugal | Centro Hospitalar Universitário de Santo António | Porto | |
Portugal | Centro Hospitalar Vila Nova de Gaia e Espinho | Vila Nova de Gaia | Porto |
Portugal | Centro Hospitalar de Trás-os-Montes e Alto Douro | Vila Real | |
Portugal | Centro Hospitalar Tondela Viseu | Viseu |
Lead Sponsor | Collaborator |
---|---|
Hospital do Divino Espírito Santo de Ponta Delgada |
Portugal,
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. Erratum In: Eur J Vasc Endovasc Surg. 2020 Mar;59(3):492-493. Eur J Vasc Endovasc Surg. 2020 Jul;60(1):158-159. — View Citation
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. — View Citation
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. Erratum In: Circulation. 2019 Jun 18;139(25):e1182-e1186. Circulation. 2023 Aug 15;148(7):e5. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Freedom from major limb amputation | Number of limbs surviving without above ankle amputation | 1 year | |
Primary | Target Lesion Revascularization (TLR) | Number of target lesions requiring re-intervention | 1 year | |
Primary | MALE - Major Adverse Limb Event | Composite endpoint Major Amputation, any index limb revascularization | 1 year | |
Secondary | MACE - Major Adverse Cardiovascular Event | Composite 5-point endpoint: Stroke, myocardial infarction/Acute coronary syndrome, Any limb revascularization, Decompensated Congestive Heart Failure, Cardiovascular death | 1 year | |
Secondary | All-cause Death | Death from any cause | 1 year | |
Secondary | Cardiovascular-related death | Death from cardiovascular causes | 1 year | |
Secondary | Primary Patency, Primary Assisted Patency, Secondary Potency | Patency of target lesion, without any intervention, with additional interventions | 1 year | |
Secondary | Ankle-Brachial Index | Pressure index obtained from ankle and brachial arterial measurements | 1 year | |
Secondary | Rutherford-Becker Classification | 1 year |
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