Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416644
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-04-30
Brief Title:
The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization SupPORT Registry
Sponsor:
Hospital do Divino Espírito Santo de Ponta Delgada
Organization:
Hospital do Divino Espírito Santo de Ponta Delgada
Study Overview
Official Title:
The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization SupPORT Registry
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SupPORT regist
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 infarctionAcute coronary syndrome Any limb revascularization Decompensated Congestive Heart Failure Cardiovascular death1
2 All-cause death Cardiovascular death
3 Primary Patencydefined by Duplex Ultrassound Scan DUS2 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 restenosisocclusion 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 centers participant data
System components
1 Registry Database All data regarding each participants 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 centerinvestigator will be only accessible to each centerinvestigator during the study period The Registry administrator will have access privileges to all participants data The application will provide general tablesgraphics 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 MicrosoftNET platform The web application will be developed on ASPNET 3540 The Database Management System DBMS will be Microsoft SQL Server 20122019 The used Web Server will be Microsoft IIS 70
4 Storage - The Central System and DBMS will be lodged in Safe Cloud Microsoft Azure Servers InforTucano The application address will be wwwrnsupportcom Cloud Microsoft Azure Server Characteristics
Physical Location Western Europe The Netherlands
Data backups with differential archives of the previous 15 days
Availability - 999
Anti-virus ESET File Security for Windows Server
Double-Firewall Windows Server e Microsoft Azure Firewall
Test version httptestinfortucanoptRegistoSupPORT
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 Pearsons χ2 test or the Fishers 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 010 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 95CI will be used and statistical significance will be considered for α05 All statistical analyses will be performed using Statistical Package for Social Sciences 210 IBM Inc Chicago Ill USA
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 infarctionAcute coronary syndrome Any limb revascularization Decompensated Congestive Heart Failure Cardiovascular death1
2 All-cause death Cardiovascular death
3 Primary Patencydefined by Duplex Ultrassound Scan DUS2 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 restenosisocclusion 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 centers participant data
System components
1 Registry Database All data regarding each participants 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 centerinvestigator will be only accessible to each centerinvestigator during the study period The Registry administrator will have access privileges to all participants data The application will provide general tablesgraphics 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 MicrosoftNET platform The web application will be developed on ASPNET 3540 The Database Management System DBMS will be Microsoft SQL Server 20122019 The used Web Server will be Microsoft IIS 70
4 Storage - The Central System and DBMS will be lodged in Safe Cloud Microsoft Azure Servers InforTucano The application address will be wwwrnsupportcom Cloud Microsoft Azure Server Characteristics
Physical Location Western Europe The Netherlands
Data backups with differential archives of the previous 15 days
Availability - 999
Anti-virus ESET File Security for Windows Server
Double-Firewall Windows Server e Microsoft Azure Firewall
Test version httptestinfortucanoptRegistoSupPORT
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 Pearsons χ2 test or the Fishers 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 010 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 95CI will be used and statistical significance will be considered for α05 All statistical analyses will be performed using Statistical Package for Social Sciences 210 IBM Inc Chicago Ill USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None