Clinical Trials Logo

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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06416644
Study type Interventional
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
Status Recruiting
Phase N/A
Start date April 1, 2023
Completion date December 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Active, not recruiting NCT03987061 - MOTIV Bioresorbable Scaffold in BTK Artery Disease N/A
Recruiting NCT03506633 - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients N/A
Active, not recruiting NCT03506646 - Dietary Nitrate Supplementation and Thermoregulation N/A
Active, not recruiting NCT04677725 - NEtwork to Control ATherothrombosis (NEAT Registry)
Recruiting NCT05961943 - RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients N/A
Recruiting NCT06047002 - Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
Completed NCT03185052 - Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach N/A
Recruiting NCT05992896 - A Study of Loco-Regional Liposomal Bupivacaine Injection Phase 4
Completed NCT04635501 - AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial N/A
Recruiting NCT04584632 - The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery N/A
Withdrawn NCT03994185 - The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease N/A
Withdrawn NCT03538392 - Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Recruiting NCT02915796 - Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty Phase 1
Active, not recruiting NCT02900924 - Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
Completed NCT02901847 - To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities. N/A
Not yet recruiting NCT02387450 - Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication Phase 2/Phase 3
Withdrawn NCT02126540 - Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries N/A
Not yet recruiting NCT02455726 - Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease N/A
Completed NCT02384980 - Saving Life and Limb: FES for the Elderly With PAD Phase 1