Clinical trial NCT06416644: The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)
Official title: The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Limb Ischemia
Peripheral Arterial Disease
Chronic Limb-Threatening Ischemia
Chronic Limb Ischemia
Atherosclerosis of Femoral Artery
Superficial Femoral Artery Stenosis
Superficial Femoral Artery Occlusion
Superficial Femoral Artery Disease
Superficial Femoral Artery Lesions
Popliteal Artery Occlusion
Popliteal Artery Stenosis
Popliteal Arterial Stenosis
Keywords: Supera
Vasculomimetic
Stent
Chronic limb-threatening ischemia
Chronic limb ischemia
Superficial femoral artery
popliteal artery
Lead sponsor: Hospital do Divino Espírito Santo de Ponta Delgada
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Freedom from major limb amputation
timeFrame: 1 year
measure: Target Lesion Revascularization (TLR)
timeFrame: 1 year
measure: MALE - Major Adverse Limb Event
timeFrame: 1 year
Secondary outcomes:
measure: MACE - Major Adverse Cardiovascular Event
timeFrame: 1 year
measure: All-cause Death
timeFrame: 1 year
measure: Cardiovascular-related death
timeFrame: 1 year
measure: Primary Patency, Primary Assisted Patency, Secondary Potency
timeFrame: 1 year
measure: Ankle-Brachial Index
timeFrame: 1 year
measure: Rutherford-Becker Classification
timeFrame: 1 year
Other outcomes:
Locations:
city: Faro
country: Portugal
facility: Hospital de Faro - Centro Hospitalar do Algarve
state: Algarve
city: Ponta Delgada
country: Portugal
facility: Hospital Divino Espírito Santo
state: Azores
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
state: Lisboa
city: Penafiel
country: Portugal
facility: Centro Hospitalar Tâmega e Sousa
state: Porto
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia e Espinho
state: Porto
city: Angra do Heroísmo
country: Portugal
facility: Hospital Santo Espírito Ilha Terceira
state: Terceira
city: Coimbra
country: Portugal
facility: Centro Hospitalar Universitário de Coimbra
city: Guimarães
country: Portugal
facility: Hospital da Senhora da Oliveira de Guimarães
city: Lisboa
country: Portugal
facility: Hospital de Santa Marta - Centro Hospitalar Lisboa Central
city: Lisboa
country: Portugal
facility: Hospital Egas Moniz - Centro Hospitalar Lisboa Central
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria - Centro Hospitalar Lisboa Norte
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário de Santo António
city: Porto
country: Portugal
facility: Centro Hospitalar São João
city: Vila Real
country: Portugal
facility: Centro Hospitalar de Trás-os-Montes e Alto Douro
city: Viseu
country: Portugal
facility: Centro Hospitalar Tondela Viseu
Study officials:
References:
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citation: 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.
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.