- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02080871
A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries. (VBXFLEX)
Evaluation of the Gore(R) Viabahn(R) Balloon Expandable Endoprosthesis (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Auckland, Nuova Zelanda
- Auckland City Hospital
-
-
-
-
Arizona
-
Phoenix, Arizona, Stati Uniti, 85006
- St. Luke's Medical Center
-
-
Connecticut
-
New Haven, Connecticut, Stati Uniti, 06518
- Yale University School of Medicine
-
-
District of Columbia
-
Washington, District of Columbia, Stati Uniti, 20782
- MedStar Health Research Institute
-
-
Florida
-
Miami, Florida, Stati Uniti, 33136
- University of Miami
-
Miami, Florida, Stati Uniti, 33176
- Baptist Cardiac and Vascular Institute
-
Pensacola, Florida, Stati Uniti, 32504
- Coastal Vascular Institute
-
-
Illinois
-
Elk Grove Village, Illinois, Stati Uniti, 60007
- Cardiovascular Associates
-
-
Iowa
-
West Des Moines, Iowa, Stati Uniti, 50266
- Iowa Methodist Medical Center
-
-
Kentucky
-
Louisville, Kentucky, Stati Uniti, 40202
- University of Louisville
-
-
Minnesota
-
Duluth, Minnesota, Stati Uniti, 55805
- Essentia Institute for Rural Health / St Mary's Hospital
-
Plymouth, Minnesota, Stati Uniti, 55422
- North Memorial Heart & Vascular Institute
-
-
New Jersey
-
Morristown, New Jersey, Stati Uniti, 07960
- Advanced Vascular Associates
-
Teaneck, New Jersey, Stati Uniti, 07666
- Holy Name Medical Center
-
-
New York
-
Buffalo, New York, Stati Uniti, 14203
- Research Foundation SUNY Buffalo
-
New York, New York, Stati Uniti, 10065
- Cornell University
-
-
North Dakota
-
Fargo, North Dakota, Stati Uniti, 58122
- Sanford Clinic - Clinical Research
-
-
Ohio
-
Columbus, Ohio, Stati Uniti, 43214
- Ohio Health
-
-
Pennsylvania
-
Camp Hill, Pennsylvania, Stati Uniti, 17011
- Holy Spirit Cardiovascular Institute
-
Pittsburgh, Pennsylvania, Stati Uniti, 15213
- UPMC
-
-
Rhode Island
-
Providence, Rhode Island, Stati Uniti, 02906
- The Miriam Hospital
-
-
South Carolina
-
Charleston, South Carolina, Stati Uniti, 29425
- MUSC
-
Greenville, South Carolina, Stati Uniti, 29615
- Greenville Memorial Hospital
-
-
Tennessee
-
Chattanooga, Tennessee, Stati Uniti, 37403
- University Surgical Associates
-
Kingsport, Tennessee, Stati Uniti, 37660
- Wellmont Holston Valley Medical Center
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- The Methodist Hospital
-
-
Virginia
-
Norfolk, Virginia, Stati Uniti, 23507
- Sentara Medical Group
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patient is at least 18 years old;
- Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy;
- Patient or legal representative is willing to give written informed consent;
- Patient is capable of complying with protocol requirements, including all follow-up visits;
- Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4).
- Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery;
- Patient has one or more regions of stenosis ≥ 50% in the target vessel, based on visual estimate;
- Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm;
- Patient has adequate ipsilateral blood flow including at least one sufficient (<50% stenotic) infrapopliteal run-off vessel not requiring intervention (per side to be intervened on).
- Patient has a total target lesion length visually estimated to be ≤110 mm which can be treated with a maximum of three VIABAHN BX endoprostheses;
- Patient has no more than two discrete ipsilateral lesions that can be treated with no more than three VIABAHN BX endoprostheses [OR] Patient has bilateral disease consisting of only one target lesion per side that can be treated with no more than a total of three VIABAHN BX endoprostheses;
- Patient has the device advanced across the target lesion(s) and positioned for deployment.
Exclusion Criteria:
- Patient has a life expectancy of less than 1 year;
- Patient has a known allergy to stent graft components, including stainless steel or heparin;
- Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol;
- Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation
- Patient has an uncorrected bleeding disorder (platelet count < 80,000/µL);
- Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL) and not on hemodialysis;
- Patient has a known hypercoagulability that cannot be corrected;
- Patient has evidence of a blood borne infection;
- Patient has had vascular access/catheterization in the lower extremity within 30 days of study enrollment;
- Patient has had a previous or planned coronary intervention within 30 days prior to enrollment in this study or required at time of study procedure;
- Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the index procedure;
- Patient is currently participating in this or another investigative clinical study.
- Patient has a stent or stent graft located within or immediately adjacent (≤5mm) to study lesion(s);
- Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s);
- Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device;
- Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery;
- Patient has a target lesion situated in such a way that an implanted device will prevent blood flow or perfusion to the internal iliac artery if patent.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Gore VIABAHN BX
Stenting espandibile con palloncino della malattia occlusiva iliaca
|
Balloon expandable stenting of iliac occlusive disease.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Composite of Major Adverse Events (MAEs)
Lasso di tempo: 9 months
|
Percentage of study subjects experiencing a major adverse event (MAE) defined as: device or procedure-related death within 30 days, myocardial infarction (MI) within 30 days, target lesion revascularization (TLR) within 9 months or major amputation of the target limb within 9 months.
|
9 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Acute Procedural Success
Lasso di tempo: Discharge
|
Number of subjects who experienced Acute Procedural Success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge.
|
Discharge
|
30-Day Clinical Success
Lasso di tempo: 30 Days
|
Number of subjects who experienced 30-Day Clinical Success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related SAEs within 30 days of the index procedure.
|
30 Days
|
Percentage of Participants With Primary Patency
Lasso di tempo: 30 Days
|
Kaplan-Meier estimate of primary patency at 30 days.
|
30 Days
|
Percentage of Participants With Primary Patency
Lasso di tempo: 9 Months
|
Kaplan-Meier estimate of primary patency at 9 months.
|
9 Months
|
Percentage of Participants With Primary Assisted Patency
Lasso di tempo: 30 Days
|
Kaplan-Meier estimate of primary assisted patency at 30 days.
|
30 Days
|
Percentage of Participants With Primary Assisted Patency
Lasso di tempo: 9 Months
|
Kaplan-Meier estimate of primary assisted patency at 9 months.
|
9 Months
|
Percentage of Participants With Secondary Patency
Lasso di tempo: 30 Days
|
Kaplan-Meier estimate of secondary patency at 30 days.
|
30 Days
|
Percentage of Participants With Secondary Patency
Lasso di tempo: 9 Months
|
Kaplan-Meier estimate of secondary patency at 9 months.
|
9 Months
|
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Lasso di tempo: 30 Days
|
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days.
|
30 Days
|
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Lasso di tempo: 9 Months
|
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 9 months.
|
9 Months
|
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Lasso di tempo: 30 Days
|
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days.
|
30 Days
|
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Lasso di tempo: 9 Months
|
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 9 months.
|
9 Months
|
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Lasso di tempo: 30 Days
|
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days.
|
30 Days
|
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Lasso di tempo: 9 Months
|
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 9 months.
|
9 Months
|
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Lasso di tempo: 30 Days
|
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 30 days.
|
30 Days
|
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Lasso di tempo: 9 Months
|
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 9 months
|
9 Months
|
Number of Participants With Change in Rutherford Category
Lasso di tempo: 30 Days
|
Number of participants with change in Rutherford Category from pre-procedure at 30 days. Rutherford Categories: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene |
30 Days
|
Number of Participants With Change in Rutherford Category
Lasso di tempo: 9 Months
|
Number of participants with change in Rutherford Category from pre-procedure at 9 months. Rutherford Categories: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene |
9 Months
|
Change in Ankle Brachial Index (ABI)
Lasso di tempo: 30 Days
|
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms.
A normal resting ABI is .9 to 1.3.
A resting ABI of less than .9 is abnormal.
An outcome of a mean ABI above .9
and below 1.3 is considered a success.
|
30 Days
|
Change in Ankle Brachial Index (ABI)
Lasso di tempo: 9 Months
|
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms.
A normal resting ABI is .9 to 1.3.
A resting ABI of less than .9 is abnormal.
An outcome of a mean ABI above .9
and below 1.3 is considered a success.
|
9 Months
|
Number of Participants With Change in Functional Status - EQ5D - Mobility
Lasso di tempo: 30 Days
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Mobility) from pre-procedure at 30 days.
|
30 Days
|
Number of Participants With Change in Functional Status - EQ5D - Mobility
Lasso di tempo: 9 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 9 months.
|
9 Months
|
Number of Participants With Change in Functional Status - EQ5D - Self Care
Lasso di tempo: 30 Days
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Self Care) from pre-procedure at 30 days.
|
30 Days
|
Number of Participants With Change in Functional Status - EQ5D - Self Care
Lasso di tempo: 9 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 9 months.
|
9 Months
|
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Lasso di tempo: 30 Days
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days.
|
30 Days
|
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Lasso di tempo: 9 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 9 months.
|
9 Months
|
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Lasso di tempo: 30 Days
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days.
|
30 Days
|
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Lasso di tempo: 9 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 9 months.
|
9 Months
|
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Lasso di tempo: 30 Days
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days.
|
30 Days
|
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Lasso di tempo: 9 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 9 months.
|
9 Months
|
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Lasso di tempo: 30 Days
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days.
|
30 Days
|
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Lasso di tempo: 9 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 9 months.
|
9 Months
|
Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ)
Lasso di tempo: 30 Days
|
Patient reported outcome based on study questionnaire.
Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.
|
30 Days
|
Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ)
Lasso di tempo: 9 Months
|
Patient reported outcome based on study questionnaire.
Percentage of subjects with improvement on WIQ from pre-procedure at 9 months.
|
9 Months
|
Percentage of Participants With Primary Patency
Lasso di tempo: 12 Months
|
Kaplan-Meier estimate of primary patency at 12 months.
|
12 Months
|
Percentage of Participants With Primary Assisted Patency
Lasso di tempo: 12 Months
|
Kaplan-Meier estimate of primary assisted patency at 12 months.
|
12 Months
|
Percentage of Participants With Secondary Patency
Lasso di tempo: 12 Months
|
Kaplan-Meier estimate of secondary patency at 12 months.
|
12 Months
|
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Lasso di tempo: 12 Months
|
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 12 months.
|
12 Months
|
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Lasso di tempo: 24 Months
|
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 24 months.
|
24 Months
|
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
Lasso di tempo: 36 Months
|
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 36 months.
|
36 Months
|
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Lasso di tempo: 12 Months
|
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months.
|
12 Months
|
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Lasso di tempo: 24 Months
|
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 24 months.
|
24 Months
|
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
Lasso di tempo: 36 Months
|
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 36 months.
|
36 Months
|
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Lasso di tempo: 12 Months
|
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 12 months.
|
12 Months
|
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Lasso di tempo: 24 Months
|
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 24 months.
|
24 Months
|
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
Lasso di tempo: 36 Months
|
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 36 months.
|
36 Months
|
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Lasso di tempo: 12 Months
|
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 12 months
|
12 Months
|
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Lasso di tempo: 24 Months
|
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 24 months
|
24 Months
|
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
Lasso di tempo: 36 Months
|
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 36 months
|
36 Months
|
Number of Participants With Change in Rutherford Category
Lasso di tempo: 12 Months
|
Number of participants with change in Rutherford Category from pre-procedure at 12 months. Rutherford Categories: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene |
12 Months
|
Number of Participants With Change in Rutherford Category
Lasso di tempo: 24 Months
|
Number of participants with change in Rutherford Category from pre-procedure at 24 months. Rutherford Categories: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene |
24 Months
|
Number of Participants With Change in Rutherford Category
Lasso di tempo: 36 Months
|
Number of participants with change in Rutherford Category from pre-procedure at 36 months. Rutherford Categories: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene |
36 Months
|
Change in Ankle Brachial Index (ABI)
Lasso di tempo: 12 Months
|
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms.
A normal resting ABI is .9 to 1.3.
A resting ABI of less than .9 is abnormal.
An outcome of a mean ABI above .9
and below 1.3 is considered a success.
|
12 Months
|
Change in Ankle Brachial Index (ABI)
Lasso di tempo: 24 Months
|
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms.
A normal resting ABI is .9 to 1.3.
A resting ABI of less than .9 is abnormal.
An outcome of a mean ABI above .9
and below 1.3 is considered a success.
|
24 Months
|
Change in Ankle Brachial Index (ABI)
Lasso di tempo: 36 Months
|
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms.
A normal resting ABI is .9 to 1.3.
A resting ABI of less than .9 is abnormal.
An outcome of a mean ABI above .9
and below 1.3 is considered a success.
|
36 Months
|
Number of Participants With Change in Functional Status - EQ5D - Mobility
Lasso di tempo: 12 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 12 months.
|
12 Months
|
Number of Participants With Change in Functional Status - EQ5D - Mobility
Lasso di tempo: 24 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 24 months.
|
24 Months
|
Number of Participants With Change in Functional Status - EQ5D - Mobility
Lasso di tempo: 36 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 36 months.
|
36 Months
|
Number of Participants With Change in Functional Status - EQ5D - Self Care
Lasso di tempo: 12 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 12 months.
|
12 Months
|
Number of Participants With Change in Functional Status - EQ5D - Self Care
Lasso di tempo: 24 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 24 months.
|
24 Months
|
Number of Participants With Change in Functional Status - EQ5D - Self Care
Lasso di tempo: 36 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 36 months.
|
36 Months
|
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Lasso di tempo: 12 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 12 months.
|
12 Months
|
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Lasso di tempo: 24 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 24 months.
|
24 Months
|
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
Lasso di tempo: 36 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 36 months.
|
36 Months
|
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Lasso di tempo: 12 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 12 months.
|
12 Months
|
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Lasso di tempo: 24 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 24 months.
|
24 Months
|
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
Lasso di tempo: 36 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 36 months.
|
36 Months
|
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Lasso di tempo: 12 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 12 months.
|
12 Months
|
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Lasso di tempo: 24 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 24 months.
|
24 Months
|
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
Lasso di tempo: 36 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 36 months.
|
36 Months
|
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Lasso di tempo: 12 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 12 months.
|
12 Months
|
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Lasso di tempo: 24 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 24 months.
|
24 Months
|
Number of Participants With Change in Functional Status - EQ5D - Own Health State
Lasso di tempo: 36 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 36 months.
|
36 Months
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Device or Procedure-related Death
Lasso di tempo: 30 Days
|
Number of subjects experiencing a device or procedure-related death within 30 Days - Component of primary outcome
|
30 Days
|
Myocardial Infarction (MI)
Lasso di tempo: 30 Days
|
Number of subjects experiencing a myocardial infarction (MI) within 30 Days - Component of primary outcome
|
30 Days
|
Target Lesion Revascularization (TLR)
Lasso di tempo: 9 Months
|
Number of subjects experiencing a target lesion revascularization (TLR) within 9 months - Component of primary outcome
|
9 Months
|
Major Amputation
Lasso di tempo: 9 Months
|
Number of subjects experiencing a major amputation of the target limb within 9 months - Component of primary outcome
|
9 Months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Jean Bismuth, MD, The Methodist Hospital Research Institute
Pubblicazioni e link utili
Pubblicazioni generali
- Panneton JM, Bismuth J, Gray BH, Holden A. Three-Year Follow-up of Patients With Iliac Occlusive Disease Treated With the Viabahn Balloon- Expandable Endoprosthesis. J Endovasc Ther. 2020 Oct;27(5):728-736. doi: 10.1177/1526602820920569. Epub 2020 Apr 24.
- Bismuth J, Gray BH, Holden A, Metzger C, Panneton J; VBX FLEX Study Investigators. Pivotal Study of a Next-Generation Balloon-Expandable Stent-Graft for Treatment of Iliac Occlusive Disease. J Endovasc Ther. 2017 Oct;24(5):629-637. doi: 10.1177/1526602817720463. Epub 2017 Jul 12.
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BES 10-07
Informazioni su farmaci e dispositivi, documenti di studio
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