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This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving or expected to require hemodialysis through a prosthetic vascular graft within 30 days. Gore proposes to demonstrate that the 6 month cumulative patency of the GORE® ACUSEAL Vascular Graft is similar to that of other arteriovenous grafts (AVGs). > >>
>
>> A total of 138 Subjects will be enrolled. Once the study procedure has been successfully completed, cannulation may occur at any time at the Investigator's discretion. >
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>
>> Subjects will be selected from up to 20 Investigational Sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GORE® ACUSEAL Vascular Graft | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® ACUSEAL Vascular Graft | Device | Surgical implantation of the GORE® ACUSEAL Vascular Graft for Hemodialysis per the Investigator's standard of practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Patency at 6 Months | Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month. | 6 Months |
| Freedom From Bleeding at 6 Months | Percentage of subjects free from both major and minor bleeding events, assessed at 6-months | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Unassisted Patency at 6 Months | The primary unassisted patency is defined as the percentage of subjects free from the first occurence of either access thrombosis or an access procedure performed to maintain access patency. | 6 Months |
| Time to Event Analysis (Cumulative Patency) |
Not provided
Inclusion Criteria:>
Patient requires the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease. >
>>
Patient is currently on hemodialysis or ready to begin hemodialysis within 30 days following placement of study device. > >>
The patient must be able to have the vascular access graft placed in an upper extremity. >
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The patient is 18 years of age or older. >
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The patient has a reasonable expectation of remaining on hemodialysis for 12 months. >
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The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements. > >>
The patient or his/her legal guardian is willing to provide informed consent. >
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>
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>> Exclusion Criteria:>
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The patient has a documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.>
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The patient currently has a known or suspected systemic infection.>
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The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.>
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The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin. >
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The patient is being considered for a live (living donor either related or unrelated to patient) donor kidney transplant.>
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The patient is enrolled in another investigational study.>
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The patient has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.>
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Study device is intended to be used temporarily.>
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The patient has had >2 previous arteriovenous accesses in treatment arm.>
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Patient is taking Aggrenox®.>
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The patient is in need of, or is scheduled for a different vascular surgical procedure within 30 days of the study procedure.>
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The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone(>10 mg), cyclosporine, tacrolimus or cyclophosphamide.>
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The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.>
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Life expectancy is less than 12 months.>
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The patient is pregnant.>
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The patient is a poor compliance risk (i.e. history of IV or oral drug abuse).
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| Name | Affiliation | Role |
|---|---|---|
| Marc Glickman, MD | Sentara Vascular Specialists | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25953016 | Derived | Glickman MH, Burgess J, Cull D, Roy-Chaudhury P, Schanzer H. Prospective multicenter study with a 1-year analysis of a new vascular graft used for early cannulation in patients undergoing hemodialysis. J Vasc Surg. 2015 Aug;62(2):434-41. doi: 10.1016/j.jvs.2015.03.020. Epub 2015 May 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GORE® ACUSEAL Vascular Graft | GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GORE® ACUSEAL Vascular Graft | GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Patency at 6 Months | Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month. | All subjects with unknown cumulative patency status at the 6 month window were omitted from calculations | Posted | Number | 95% Confidence Interval | percentage of participants | 6 Months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GORE® ACUSEAL Vascular Graft | GORE® ACUSEAL Vascular Graft |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Debby Pfile, Clinical Research Associate | W. L. Gore & Associates | 623-234-5226 | dpfile@wlgore.com |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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The cumulative patency at 6 months and time-to-loss of cumulative patency will be estimated using the Kaplan-Meier survival curve for time-to-event analysis to obtain estimates accounting for censoring. |
| 6 Months |
| Time to First Cannulation | The time to first cannulation is defined as the time from access placement to the first cannulation of the GORE® ACUSEAL Vascular Graft. | Time of access placement to first cannulation, assessed up to one week |
| Time to Potential Central Venous Catheter Removal | The time to potential central venous catheter removal is defined as the time from the initial study procedure to the third consecutive cannulation through the GORE® ACUSEAL Vascular Graft in which hemodialysis is carried out. The third consecutive cannulation is a surrogate endpoint for time to CVC removal. Typically, CVC removal is ordered after the third consecutive cannulation. | Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Freedom From Bleeding at 6 Months | Percentage of subjects free from both major and minor bleeding events, assessed at 6-months | All subjects with unknown bleeding status at the 6 month window were omitted from calculations | Posted | Number | 95% Confidence Interval | percentage of participants | 6 Months |
|
|
|
| Secondary | Primary Unassisted Patency at 6 Months | The primary unassisted patency is defined as the percentage of subjects free from the first occurence of either access thrombosis or an access procedure performed to maintain access patency. | All subjects with unknown primary unassisted patency status at the 6 month window were omitted from calculations | Posted | Number | percentage of participants | 6 Months |
|
|
|
| Secondary | Time to Event Analysis (Cumulative Patency) | The cumulative patency at 6 months and time-to-loss of cumulative patency will be estimated using the Kaplan-Meier survival curve for time-to-event analysis to obtain estimates accounting for censoring. | All subjects with unknown time to event analysis (cumulative patency) status at the 6 month window were omitted from calculations | Posted | Number | 95% Confidence Interval | percentage of participants | 6 Months |
|
|
|
| Secondary | Time to First Cannulation | The time to first cannulation is defined as the time from access placement to the first cannulation of the GORE® ACUSEAL Vascular Graft. | All subjects with unknown time to first cannulation at the 6 month window were omitted from calculations | Posted | Number | percentage of grafts | Time of access placement to first cannulation, assessed up to one week |
|
|
|
| Secondary | Time to Potential Central Venous Catheter Removal | The time to potential central venous catheter removal is defined as the time from the initial study procedure to the third consecutive cannulation through the GORE® ACUSEAL Vascular Graft in which hemodialysis is carried out. The third consecutive cannulation is a surrogate endpoint for time to CVC removal. Typically, CVC removal is ordered after the third consecutive cannulation. | All subjects with unknown time to potential central venous catheter removal at the 6 month window were omitted from calculations | Posted | Median | Full Range | days | Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123 |
|
|
|
| 74 |
| 138 |
| 0 |
| 138 |
| Anemia aggravated | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Chronic thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Atrial fibrillation with rapid ventricular response | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Atrial tachycardia | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Cardiac arrhythmia | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Cardiopulmonary arrest | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Chest pain - cardiac | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Congestive heart failure | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Diastolic heart failure | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Non ST segment elevation myocardial infarction | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Non STEMI | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Non-sustained ventricular tachycardia | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Pulseless electrical activity | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| STEMI | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| SVT | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Unstable angina | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Polycystic kidney | Congenital, familial and genetic disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Diabetic gastroparesis | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Erosive esophagitis | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| GI bleed | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Gastric polyps | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Gastrointestinal bleed | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Gastroparesis | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Ileitis | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Large intestine mass | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Peptic ulcer disease | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Rectal bleeding | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Edema extremity upper | General disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Edema face | General disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Fever | General disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Multi organ failure | General disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Swelling arm | General disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Liver failure | Hepatobiliary disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Appendicitis perforated | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Arteriovenous graft site cellulitis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Arteriovenous graft site infection | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Bacterial endocarditis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Cellulitis of hand | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Community acquired pneumonia | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Enterococcal sepsis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Graft infection | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Hematoma infection | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Incision site infection | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Infected toe | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Peripheral gangrene | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Septicemia | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Staphylococcal bacteremia | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Staphylococcus aureus bacteremia | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Staphylococcus epidermidis infection | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Urinary tract infection pseudomonal | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Wound infection due to staphylococcus aureus | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
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| Anastomotic ulcer hemorrhage | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
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| Arteriovenous graft site hemorrhage | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
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| Bleeding of suture site | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
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| Burst fracture | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
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| Suture related complication | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
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| Wrist fracture | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
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| Pulseless | Investigations | MedDRA Version 13.1 | Systematic Assessment |
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| Acidosis | Metabolism and nutrition disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Failure to thrive | Metabolism and nutrition disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Volume overload | Metabolism and nutrition disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Hand pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
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| Colonic neoplasm NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
|
| Gastrointestinal stromal tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
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| Malignant neoplasm of pleura | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
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| Multiple myeloma progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
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| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
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| Pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
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| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
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| Anoxic encephalopathy | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
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| CVA | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Encephalopathy acute | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Ischemic neuropathy | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Stroke | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Acute confusional state | Psychiatric disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA Version 13.1 | Systematic Assessment |
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| End stage renal disease (ESRD) | Renal and urinary disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Hypercapnic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Renal transplant | Surgical and medical procedures | MedDRA Version 13.1 | Systematic Assessment |
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| Critical limb ischemia | Vascular disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Embolism | Vascular disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Hypertension worsened | Vascular disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Hypertensive urgency | Vascular disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Peripheral ischemia | Vascular disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Peripheral vascular disease | Vascular disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Steal syndrome | Vascular disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Uncontrolled hypertension | Vascular disorders | MedDRA Version 13.1 | Systematic Assessment |
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Gore has the right to review disclosures, requesting a delay of less than 90 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating sites.
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Cannulated within 1 week of procedure |
|