The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)

Peripheral Arterial Disease Clinical Trial

— SupPORT regist  

Official title:

The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06416644
• Other study ID #: S-HDES-2023-309
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Hospital do Divino Espírito Santo de Ponta Delgada
• Contact: Nelson FG Oliveira, MD, PH.D
• Phone: (+351)296203000
• Email: Nelson.FG.Oliveira[@]azores.gov.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Primary endpoints (at hospitalization, 30 days, 6 months, 1 year)

1. Limb salvage

2. Target lesion revascularization (TLR)

3. Freedom from major adverse limb events (MALE - Major Amputation, any index limb revascularization)

Secondary endpoints (at hospitalization, 30 days, 6 months, 1 year)

1. Freedom from Major adverse cardiovascular events (5-point endpoint: Stroke, myocardial infarction/Acute coronary syndrome, Any limb revascularization, Decompensated Congestive Heart Failure, Cardiovascular death1)

2. All-cause death / Cardiovascular death

3. Primary Patency(defined by Duplex Ultrassound Scan [DUS]2) Primary-Assisted Patency, Secondary Patency

4. Ankle-Brachial Index (ABI)

5. Rutherford-Becker classification

Inclusion Criteria Clinical

• Evidence of symptomatic obstructive peripheral arterial disease

• Individuals aged 18 and older

• 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.

Angiographic

• 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)

Procedure Protocol - Endovascular revascularization

• Participating centers are invited to maintain local practice standards, used in endovascular peripheral arterial revascularization. Pre-implant ballooning and peri-interventional anti-thrombotic therapy will be captured by the database. Intra-procedural and peri-procedural adjuncts are allowed, and will be recorded.

Follow-up Protocol

• Minimum follow-up will include a clinical assessment up to 30-days post-intervention, at 6 months, and at 1 year. Routine ABI is mandatory. Routine DUS is recommended.

• Post-interventional anti-thrombotic therapy will be captured by the database, and will follow international recommendations, but also local practice standards and will be at the discretion of the assisting-physician.

Data collection and storage

• Data will be inserted at each center by the Investigation team on an electronic platform, created and managed by Infortucano.

• Principal Investigators will have access to the enrolled center's participant data.

• System components

1. Registry Database All data regarding each participant's records will be anonymously collected in a Central Database, where it will be stored. There are no limits to the number of participating centers.

2. Web Application - SupPORT Registry

1. Registry - The application will run on internet browser, with individual user authentication required for each Principal investigator. This application will allow the recording of the data and follow-up data by each participating center.

2. Information extraction - Inserted data by each center/investigator will be only accessible to each center/investigator during the study period. The Registry administrator will have access privileges to all participants' data. The application will provide general tables/graphics with generic information throughout the study period, accessible to all investigators (number or participants per center, overall inclusion, to be defined). All inserted data will be exportable to CSV files, allowing import to Microsoft Excel or SPSS software.

3. Technological architecture - All components are developed Microsoft.NET platform. The web application will be developed on ASP.NET 3.5/4.0. The Database Management System (DBMS) will be Microsoft SQL Server 2012/2019. The used Web Server will be Microsoft IIS 7.0.

4. Storage - The Central System and DBMS will be lodged in Safe Cloud Microsoft Azure Servers (InforTucano). The application address will be www.rnsupport.com. Cloud Microsoft Azure Server Characteristics:

• Physical Location: Western Europe (The Netherlands)

• Data backups with differential archives of the previous 15 days

• Availability - 99,9 %

• Anti-virus ESET File Security for Windows Server

• Double-Firewall (Windows Server e Microsoft Azure Firewall)

• Test version: http://test.infortucano.pt/RegistoSupPORT

• User: admin

• Pwd: admin123

Statistical analysis Statistical analysis: Continuous variables with a normal distribution will be described as mean and standard deviation. Continuous variables are presented as median and interquartile range (IQR) if skewed and will be tested among groups using the Mann-Whitney U-Test for independent samples. Related variables will be compared with the Wilcoxon Signed Rank Test. Categorical variables will be presented as count and percentage and will be compared using the Pearson's χ2 test or the Fisher´s exact test in cases of low number of events. Life-table based analyses will be used for endpoint assessment. Kaplan-Meier curves will be created, and differences tested according to the log rank test. For association between baseline characteristics endpoints, a multivariable logistic regression model (including time as a co-variate) or a Cox hazards proportion model will be created including variables with α-value ≤0.10 on univariate analysis, if appropriate. Stepwise backward elimination of variables with a P-value >.050 will be also used during multivariable modelling. Confidence-intervals of 95% (95%CI) will be used and statistical significance will be considered for α<.05. All statistical analyses will be performed using Statistical Package for Social Sciences 21.0 (IBM Inc, Chicago, Ill, USA).

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Atherosclerosis
• Atherosclerosis of Femoral Artery
• Chronic Limb Ischemia
• Chronic Limb-Threatening Ischemia
• Constriction, Pathologic
• Ischemia
• Lower Limb Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Popliteal Arterial Stenosis
• Popliteal Artery Occlusion
• Popliteal Artery Stenosis
• Superficial Femoral Artery Disease
• Superficial Femoral Artery Lesions
• Superficial Femoral Artery Occlusion
• Superficial Femoral Artery Stenosis

Intervention

Device:
• Supera Vasculomimetic Stent
Femoral-popliteal revascularization with Supera Stent

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Divino Espírito Santo de Ponta Delgada

Country where clinical trial is conducted

Portugal, 

References & Publications (5)

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

Outcome

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