The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)
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
Sponsor: Hospital do Divino Espírito Santo de Ponta Delgada

The PORTuguese Registry of Supera 
supported femoral-popliteal 
revascularization  
 
SupPORT registry 
 
 
 
 
Study protocol – V1 
Date: April 1st 2023. 
 
 
 

Primary endpoints (at hospitalization, 30 days, 6 months, 1 year)  
1. Limb salvage (freedom from major amputation). 
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  
 a. 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.  
b. 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. 

c. 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. 
d. 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 
o 
User: admin 
o 
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). 
 
 

Variable List 
1. Identifiers 
 
1. Registry number ID (Code) 
 
2. Demographic 
1. Age 
2. Gender 
3. Weight 
4. American Society of Anesthesiology Classification 
 
3. Comorbidities 
1. Diabetes Mellitus 
2. Renal function – Seric Creatinine 
3. Hemodialysis status 
4. Smoking habits (current, previous, non-smoker). 
5. Smoking - Pack/year units 
6. Hypertension 
7. Cerebrovascular disease 
8. Coronary ischemic disease 
9. Congestive Heart Failure 
10. Previous Contralateral Major Amputation 
11. Baseline antithrombotic medication (pre-admission)  
12. Baseline statin therapy (pre-admission, none/low/high intensity)3.  
 
4. Peripheral arterial disease  
1. Lower Limb laterality  
2. Rutherford-Becker classification 
3. Trophic lesion severity – according to WIFi classification4   
4. Calcaneal involvement by trophic lesion  
5. Trophic lestion infection (according to WIFI classification) 
6. Ankle-Brachial index, baseline 
7. Any previous intervention of the superficial femoral (SFA) or popliteal artery ? Descriptive.   
 
5. Index lesion classification 
1. GLASS classification – all sectors of index limb.5 
i. Femoral-popliteal 
ii. Infrapopliteal 
iii. Below-the-ankle 
iv. Global Classification (I to III) 
2. Lesion length (Short - <25cm / Long >25cm)  
3. Calcification (Peripheral Artery Calcification Scoring System)6 
 
6. Intervention 
1. Date 
2. Systemic heparinization (UI/kg) (dose) 
3. Pre-dilation – maximum balloon diameter 
4. Use of other adjuvants in lesion preparation (Descriptive 
5. Supera implant – diameter 
6. Supera implant – total stent length implanted  

7. Supera implant – Compressed)/Nominal/Elongated)  (overall stent assessment – if length  
< or > than 10% of the nominal length, then stent is considered compressed or elongated, 
respectively) 
8. Supera implant – nº of stents used (1, >1) 
9. SUPERA location (SFA- proximal, SFA- distal/proximal popliteal artery; distal popliteal 
artery) 
10. Adjuvant inflow intervention (at time of Supera implant, before, or after during index 
hospitalization, yes/no and descriptive)  
11. Adjuvant below-the-knee intervention (at time of Supera implant, before, or after during 
index hospitalization, yes/no and descriptive)  
12. Technical success (Stenosis ≤30% or pressure gradient ≤10mmHg) 
13. Direct inline flow to flow obtained? (yes/no) 
14. Below-the-knee runoff vessels (1/2/3) 
15. Unexpected procedural events (descriptive) (may include non-treated non-flow-limiting 
dissection – grade A or B according to the NHLBI classification, other adjuvant 
interventions following Supera implant).  
16. Adverse intraprocedural events  – descriptive ( thromboembolic – stent thrombosis, distal 
embolization, catheter aspiration thrombectomy, thrombolysis, conversion to open 
surgery, arterial rupture, conversion to covered stent, others.  
 
17. Post-procedural data – early (during index admission),  
18. Complications? – 
1. Stent thrombosis 
2. Residual stenosis in Supera-stented segment 
3. Hematome/Pseudoaneurysm 
4. Acute myocardial infarct / Stroke 
5. Renal impairement /hemodialysis 
17. Mortality 
1. Related or not with procedure? 
2. Cause of death 
19. ABI – post-procedural  
20. Major amputation?  
21. Discharge date 
7. Follow-up data (30 day assessment, 6 month, 12 month  
1. Follow-up evaluation 
i. Date 
ii. ABI 
iii. Duplex ultrasound performed? (Yes/no)  
1. Permeability? Stenosis (PSV ratio ≥2.5 indicates ≥50% stenosis) 
iv. Lesion healing (yes/no/ favourable) 
v. Rutherford-Becker classification 
2. Major amputation?  
i. If yes - Date 
3. Target Lesion Revascularization (TLR)  
i. If yes - Date 
4. MALE (Major Adverse Limb Event 
i. If yes - Date 
5. Major Adverse Cardiovascular Event  
i. If yes - Date 
6. Death 
i. If yes – Date  
ii. Cause of death 
 

Bibliographic references 
1. Bosco E; Hsueh L, McConeghy KW; et al.  Major adverse cardiovascular event defnitions used 
in observational analysis of administrative databases: a systematic review. BMC Med Res Methodol 
(2021) 21:241.https://doi.org/10.1186/s12874-021-01440-5 
2. 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. 
3. 2018 AHA/ACC/AACVPR/AAPA/ ABC/ACPM/ADA/AGS/APhA/ ASPC/NLA/PCNA Guideline on the 
Management of Blood Cholesterol: Executive Summary, JACC VOL. 73, NO. 24, 2019 
https://doi.org/10.1016/j.jacc.2018.11.002 
4. Mills, J.L; Conte M.S.; Armstrong D.G.; Pomposelli F.B.; Schanzer A.; Sidway A.N.; et al. 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; 59:220-34. 
5. Conte M.S.; Bradbury A.W.; Kolh P.; White J.V.; Dick F.; Fitridge R.; Mills J.L.; et al. Global Vascular 
Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg 
2019, 58:S1-S109. 
6. Rocha-Singh K.J.; Zeller T.; Jaff M.R. Peripheral arterial calcification: prevalence, mechanism, 
detection, and clinical implications. Catheter Cardiovasc Interv. 2014; 83(6):E212-20. doi: 
10.1002/ccd.25387. Epub 2014 Feb 10. 
 
 
 
Key words 
Supera, Vasculomimetic, Stent, Chronic limb-threatening ischemia, Chronic limb ischemia, 
Superficial femoral artery, Popliteal artery. 
 
Conditions 
Lower limb ischemia, peripheral arterial disease, chronic limb-threatening ischemia, chronic limb 
ischemia, atherosclerosis femoral artery, superficial/popliteal femoral artery 
stenosis/occlusion/disease