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Prospective, multicenter, non-randomized, single-arm registry to evaluate the safety and effectiveness of the iCAST Covered Stent System in the treatment of patients with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery.
STUDY DESIGN: Prospective, multicenter, non-randomized, single-arm registry
OBJECTIVE: The primary objective is to evaluate the iCAST covered stent to a performance metric derived from studies of FDA-approved iliac stent devices for treating iliac artery stenoses in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
NUMBER OF SUBJECTS: 165 subjects, including up to 25 subjects with totally occluded lesions.
PRIMARY ENDPOINTS: The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization or restenosis (by ultrasound determination) within 9 months post-procedure.
SECONDARY ENDPOINTS: Secondary endpoints include:
PATIENT POPULATION: Eligible patients have symptomatic claudication or rest pain and angiographic confirmation of either de novo or restenotic lesions in the common and/or external iliac artery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iCAST covered stent | Other | This is a one arm trial. All subjects received the iCAST covered stent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iCAST covered stent | Device | Iliac stent implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis | The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization within 9 months or restenosis (by ultrasound determination) at 9 months. | Within 9 Months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Procedural Success | Device success and achievement of < 30% residual stenosis immediately after stent placement and without occurrence of in-hospital MAVE. | Post-procedure |
| Device Success |
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Inclusion Criteria:
Exclusion Criteria:
Presence of other non-target ipsilateral arterial lesions requiring treatment within 30 days post-procedure (Note that treatment of ipsilateral SFA lesions may be allowed under certain circumstances). Treatment of lesions in any other vascular bed must be completed at least 30 days prior to enrollment.
The target lesion(s) has adjacent, acute thrombus.
The target lesion(s) is highly calcified or was previously treated with a stent.
Target lesion involves the internal iliac artery resulting in crossing of the side-branch with the iCAST device (e.g. "jailing" of the side-branch).
Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion.
Subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery prior to initiation of the iCAST implant procedure.
Subject has a post-surgical stenosis and anastomotic suture treatments of the target vessel.
Subject has a vascular graft previously implanted in the native iliac vessel.
Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has a hypersensitivity to stainless steel, expanded polytetrafluoroethylene (ePTFE) or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications.
History of neutropenia (WBC <3,000/mm3), coagulopathy, or thrombocytopenia (platelet count <80,000/ μL) that has not resolved or has required treatment in the past 6 months.
Known bleeding or hypercoagulability disorder or significant anemia (Hb< 8.0) that cannot be corrected.
Subject has the following laboratory values:
Subject requires general anesthesia for the procedure.
Subject is pregnant.
Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. Note: Subjects who are participating in the long term follow-up phase of a previously investigational and now FDA-approved product are not excluded by this criterion.
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| Name | Affiliation | Role |
|---|---|---|
| John R Laird, MD | Adventist Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| Fogarty Clincal Research Incorporated |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31031089 | Derived | Laird JR, Loja M, Zeller T, Niazi KAK, Foster MT, Ansel G, Stone DH, Dave RM, Popma JJ, Jaff MR, Massaro JM. iCAST Balloon-Expandable Covered Stent for Iliac Artery Lesions: 3-Year Results from the iCARUS Multicenter Study. J Vasc Interv Radiol. 2019 Jun;30(6):822-829.e4. doi: 10.1016/j.jvir.2018.12.707. Epub 2019 Apr 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Device: ICAST Covered Stent | Implantation of ≥ 1 ICAST stent |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Successful delivery and deployment of the study stent and intact retrieval of the delivery system.
| Post-procedure |
| Major Adverse Event (MAE) | Composite rate of MAVE or any death, or stroke. | 30 Days |
| Major Adverse Vascular Event (MAVE) | Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion. | 30 Days |
| Major Adverse Vascular Event (MAVE) | Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion. | 180 Days |
| Major Adverse Vascular Event (MAVE) | Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion. | 270 Days |
| Major Adverse Vascular Event (MAVE) | Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion. | 360 Days |
| Early Clinical Success | Improvement of the Rutherford-Becker clinical criteria by ≥ 1 category. (Classification system for evaluating clinical improvement as defined by Rutherford R, Becker G. Standards for evaluating and reporting the results of surgical and percutaneous therapy for peripheral arterial disease. Journal of Vascular Interventional Radiology 1991;2:169-174.) | 1 Month |
| Late Clinical Success | Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. | 6 Months |
| Late Clinical Success | Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. | 9 Months |
| Late Clinical Success | Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. | 12 Months |
| Late Clinical Success | Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. | 24 Months |
| Late Clinical Success | Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. | 36 Months |
| Primary Patency | Continuous flow without revascularization, bypass or target limb amputation. | 1 Month |
| Primary Patency | Continuous flow without revascularization, bypass or target limb amputation. | 6 Months |
| Primary Patency | Continuous flow without revascularization, bypass or target limb amputation. | 9 Months |
| Primary Patency | Continuous flow without revascularization, bypass or target limb amputation. | 12 Months |
| Primary Patency | Continuous flow without revascularization, bypass or target limb amputation. | 24 Months |
| Primary Patency | Continuous flow without revascularization, bypass or target limb amputation. | 36 Months |
| Primary-Assisted Patency | Continuous flow assisted when the target vessel has restenosed at any time post-procedure. | 1 Month |
| Primary-Assisted Patency | Continuous flow assisted when the target vessel has restenosed at any time post-procedure. | 6 Months |
| Primary-Assisted Patency | Continuous flow assisted when the target vessel has restenosed at any time post-procedure. | 9 Months |
| Primary-Assisted Patency | Continuous flow assisted when the target vessel has restenosed at any time post-procedure. | 12 Months |
| Primary-Assisted Patency | Continuous flow assisted when the target vessel has restenosed at any time post-procedure. | 24 Months |
| Primary-Assisted Patency | Continuous flow assisted when the target vessel has restenosed at any time post-procedure. | 36 Months |
| Secondary Patency | Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel. | 1 Month |
| Secondary Patency | Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel. | 6 Months |
| Secondary Patency | Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel. | 9 Months |
| Secondary Patency | Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel. | 12 Months |
| Secondary Patency | Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel. | 24 Months |
| Secondary Patency | Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel. | 36 Months |
| Mountain View |
| California |
| 94040 |
| United States |
| University of California, Davis | Sacramento | California | 95817 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| Piedmont Hospital Research Institute | Atlanta | Georgia | 30309 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Krannert Institute of Cardiology | Indianapolis | Indiana | 46202 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Terrebonne General Medical Center | Houma | Louisiana | 70360 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Mass General Hospital | Boston | Massachusetts | 02114 | United States |
| Forest General Hospital | Hattiesburg | Mississippi | 39401 | United States |
| Kansas City Heart Foundation | Kansas City | Missouri | 64132 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Lindner Clinical Trial Center | Cincinnati | Ohio | 45219 | United States |
| University Hospitals, Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| MidWest Cardiology Research Foundation | Columbus | Ohio | 43214 | United States |
| Holy Spirit Cardiovascular Institute | Camp Hill | Pennsylvania | 17011 | United States |
| North Central Heart Institute | Sioux Falls | South Dakota | 57108 | United States |
| Tennova Healthcare - Turkey Creek Medical Center | Knoxville | Tennessee | 37934 | United States |
| Cardiovascular Research Institute of Dallas | Dallas | Texas | 75231 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Herzzentrum Bad Krozingen | Bad Krozingen | Germany |
| Intention to Treat (ITT) Population | Subjects who signed written informed consent, enrolled in the study and met study entry criteria. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
ITT population was assessed for baseline measures: this includes subjects who signed the written informed consent, enrolled in the study and met the study entry criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Device: ICAST Covered Stent | Implantation of ≥ 1 ICAST stent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Cigarette Smoking Status | One subject was missing data. | Count of Participants | Participants |
| |||||||||||||||||
| Previous Peripheral Artery Revascularization/Surgery | Two subjects were missing data. | Count of Participants | Participants |
| |||||||||||||||||
| Coronary Artery Disease | One subject was missing data. | Count of Participants | Participants |
| |||||||||||||||||
| Previous Myocardial Infarction (MI) | One subject was missing data. | Count of Participants | Participants |
| |||||||||||||||||
| Previous percutaneous coronary revascularization | One subject was missing data. | Count of Participants | Participants |
| |||||||||||||||||
| Coronary Artery Bypass Graft Surgery | One subject was missing data. | Count of Participants | Participants |
| |||||||||||||||||
| Cerebrovascular Accident | Count of Participants | Participants |
| ||||||||||||||||||
| Previous Amputation | Count of Participants | Participants |
| ||||||||||||||||||
| Transient Ischemic Attack | One subject was missing data. | Count of Participants | Participants |
| |||||||||||||||||
| Diabetes Mellitus | Count of Participants | Participants |
| ||||||||||||||||||
| Hypertension | Count of Participants | Participants |
| ||||||||||||||||||
| Hypercholesterolemia | Count of Participants | Participants |
| ||||||||||||||||||
| Renal Insufficiency | Count of Participants | Participants |
|
| 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 | Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis | The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization within 9 months or restenosis (by ultrasound determination) at 9 months. | ITT population: Subjects who signed the written informed consent, enrolled in the study and met the study entry criteria. | Posted | Number | Percentage of subjects | Within 9 Months post-procedure |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Acute Procedural Success | Device success and achievement of < 30% residual stenosis immediately after stent placement and without occurrence of in-hospital MAVE. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | Post-procedure |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Device Success | Successful delivery and deployment of the study stent and intact retrieval of the delivery system. | ITT population: Subjects who signed the written informed consent, enrolled in the study and met the study entry criteria. | Posted | Count of Participants | Participants | Post-procedure |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Major Adverse Event (MAE) | Composite rate of MAVE or any death, or stroke. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 30 Days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Major Adverse Vascular Event (MAVE) | Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 30 Days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Major Adverse Vascular Event (MAVE) | Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 180 Days |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Major Adverse Vascular Event (MAVE) | Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 270 Days |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Major Adverse Vascular Event (MAVE) | Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 360 Days |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Early Clinical Success | Improvement of the Rutherford-Becker clinical criteria by ≥ 1 category. (Classification system for evaluating clinical improvement as defined by Rutherford R, Becker G. Standards for evaluating and reporting the results of surgical and percutaneous therapy for peripheral arterial disease. Journal of Vascular Interventional Radiology 1991;2:169-174.) | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 1 Month |
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| Secondary | Late Clinical Success | Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 6 Months |
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| Secondary | Late Clinical Success | Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 9 Months |
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| Secondary | Late Clinical Success | Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 12 Months |
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| Secondary | Late Clinical Success | Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 24 Months |
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| Secondary | Late Clinical Success | Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 36 Months |
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| Secondary | Primary Patency | Continuous flow without revascularization, bypass or target limb amputation. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 1 Month |
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| Secondary | Primary Patency | Continuous flow without revascularization, bypass or target limb amputation. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 6 Months |
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| Secondary | Primary Patency | Continuous flow without revascularization, bypass or target limb amputation. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 9 Months |
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| Secondary | Primary Patency | Continuous flow without revascularization, bypass or target limb amputation. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 12 Months |
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| Secondary | Primary Patency | Continuous flow without revascularization, bypass or target limb amputation. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 24 Months |
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| Secondary | Primary Patency | Continuous flow without revascularization, bypass or target limb amputation. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 36 Months |
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| Secondary | Primary-Assisted Patency | Continuous flow assisted when the target vessel has restenosed at any time post-procedure. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 1 Month |
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| Secondary | Primary-Assisted Patency | Continuous flow assisted when the target vessel has restenosed at any time post-procedure. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 6 Months |
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| Secondary | Primary-Assisted Patency | Continuous flow assisted when the target vessel has restenosed at any time post-procedure. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 9 Months |
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| Secondary | Primary-Assisted Patency | Continuous flow assisted when the target vessel has restenosed at any time post-procedure. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 12 Months |
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| Secondary | Primary-Assisted Patency | Continuous flow assisted when the target vessel has restenosed at any time post-procedure. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 24 Months |
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| Secondary | Primary-Assisted Patency | Continuous flow assisted when the target vessel has restenosed at any time post-procedure. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 36 Months |
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| Secondary | Secondary Patency | Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 1 Month |
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| Secondary | Secondary Patency | Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 6 Months |
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| Secondary | Secondary Patency | Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 9 Months |
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| Secondary | Secondary Patency | Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 12 Months |
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| Secondary | Secondary Patency | Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 24 Months |
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| Secondary | Secondary Patency | Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel. | Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria). | Posted | Count of Participants | Participants | 36 Months |
|
|
1080 Days post-procedure
Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device: ICAST Covered Stent | Implantation of ≥ 1 ICAST stent | 14 | 165 | 86 | 165 | 22 | 165 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Post procedural sepsis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Aortic injury | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Arterial injury | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Device dislocation | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| In-stent arterial restenosis | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Stent occlusion | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Urostomy complication | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Colon cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Brain mass | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Renal artery occlusion | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Renal mass | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Galactorrhoea | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Arterial restenosis | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Femoral arterial stenosis | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Femoral artery occlusion | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Iliac artery stenosis | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Subclavian artery stenosis | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Vascular pseudoaneurysm | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral artery dissection | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
No publication or publicizing of data or results without the Sponsor's prior written permission. Party wishing to publish or publicize will submit proposed manuscript or publication to Sponsor for comment at least 60 days prior to release. Publishing party will make every reasonable attempt to incorporate comments received from Sponsor during 60 day period.The publishing party won't use Sponsor's confidential information in manuscript or publication without the prior written consent of sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Bulger, Director of Clinical Affairs | Getinge | 1-603-864-5368 | elizabeth.bulger@getinge.com |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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