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The objective of this study is to evaluate the safety and efficacy of the Assurant Cobalt Iliac Stent System in the treatment of de novo and restenotic lesions in iliac arteries of subjects with Peripheral Artery Disease (PAD).
This study is being conducted to collect 9 month safety and efficacy data on the Assurant Cobalt Iliac Stent for all subjects enrolled into the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assurant Cobalt Iliac Stent | Experimental | Assurant® Cobalt Iliac Stent System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assurant® Cobalt Iliac Stent System | Device | Iliac Stenting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR). | Percentage based on number of evaluable subjects for MAE. Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated death before 240 days without having MAE events. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency Rate at 9 Months | Primary patency was defined as the blood flow through the treated vessel segment into the distal vasculature (e.g. the common femoral artery and/or the deep femoral artery) as evidenced by duplex ultrasound scan at 9 months for all subjects enrolled with evaluable duplex scans. | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert G Molnar, MD | Michigan Vascular Research Center | Principal Investigator |
| William Gray, MD | NY Presbyterian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Vascular Research Center | Flint | Michigan | 48507 | United States | ||
| NY Presbyterian Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23391088 | Derived | Molnar RG, Gray WA; ACTIVE Trial Investigators. Sustained patency and clinical improvement following treatment of atherosclerotic iliac artery disease using the Assurant cobalt iliac balloon-expandable stent system. J Endovasc Ther. 2013 Feb;20(1):94-103. doi: 10.1583/12-4010.1. |
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Recruitment was for a period of 16 months. Subjects were recruited at medical clinics who participate in clinical trials.
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| ID | Title | Description |
|---|---|---|
| FG000 | Assurant Cobalt Iliac Stent | Cobalt stent implanted using standard percutaneous intervention technique. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Assurant Cobalt Iliac Stent | Treatment with iliac stenting |
| 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 | Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR). | Percentage based on number of evaluable subjects for MAE. Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated death before 240 days without having MAE events. | Intent to Treat population (ITT) | Posted | Number | percentage of participants | 9 months |
|
From subject index procedure through the 9 month follow up visit period.
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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 | Assurant Cobalt Iliac Stent | Treatment with Iliac stenting system |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GASTROINTESTINAL DISORDERS | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CARDIAC DISORDERS | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arslan Malik - Senior Clinical Research Manager | Medtronic Aortic and Peripheral Vascular | (707) 541-3256 | arslan.malik@medtronic.com |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Device Success |
Device Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device. |
| 9 months |
| Lesion Success | Lesion Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using any percutaneous method such as baloon angioplasy or other stent. | 9 months |
| Procedure Success | Procedure Success defined as angiographic evidence of <30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MAE prior to hospital discharge (for subjects with more than one lesion stented the worse case is counted) | 9 months |
| Clinical Success | Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement. | 30 days |
| Clinical Success | Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement. | 9 months |
| Hemodynamic Success | Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level. | 30 days |
| Hemodynamic Success | Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level. | 9 months |
| All Cause Mortality | Subjects are considered unevaluable for all cause mortality at 30 days if a) withdrawn before 25 days or b) lost to follow-up before 25 days and had no contact thereafter. | 30 days |
| All Cause Mortality | Subjects are considered unevaluable for all cause mortality at 9 months if a) withdrawn before 240 days or b) lost to follow-up before 240 days and had no contact thereafter. | 9 months |
| New York |
| New York |
| 10032 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Primary Patency Rate at 9 Months | Primary patency was defined as the blood flow through the treated vessel segment into the distal vasculature (e.g. the common femoral artery and/or the deep femoral artery) as evidenced by duplex ultrasound scan at 9 months for all subjects enrolled with evaluable duplex scans. | Intent to Treat population | Posted | Number | percentage of lesions | 9 months | Lesions | Participants |
|
|
|
| Secondary | Device Success | Device Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device. | Intent to Treat population | Posted | Number | percentage of lesions | 9 months | Lesion | Participants |
|
|
|
| Secondary | Lesion Success | Lesion Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using any percutaneous method such as baloon angioplasy or other stent. | Intent to Treat population | Posted | Number | percentage of lesions | 9 months | Lesions | Participants |
|
|
|
| Secondary | Procedure Success | Procedure Success defined as angiographic evidence of <30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MAE prior to hospital discharge (for subjects with more than one lesion stented the worse case is counted) | Intent to Treat population | Posted | Number | percentage of participants | 9 months |
|
|
|
| Secondary | Clinical Success | Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement. | Intent to Treat population | Posted | Number | percentage of limbs | 30 days | Limbs | Participants |
|
|
|
| Secondary | Clinical Success | Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement. | Intent to Treat population | Posted | Number | percentage of limbs | 9 months | Limbs | Participants |
|
|
|
| Secondary | Hemodynamic Success | Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level. | Intent to Treat population | Posted | Number | percentage of limbs | 30 days | Limbs | Participants |
|
|
|
| Secondary | Hemodynamic Success | Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level. | Intent to Treat population | Posted | Number | percentage of limbs | 9 months | Limbs | Participants |
|
|
|
| Secondary | All Cause Mortality | Subjects are considered unevaluable for all cause mortality at 30 days if a) withdrawn before 25 days or b) lost to follow-up before 25 days and had no contact thereafter. | Intent to Treat population | Posted | Number | participants | 30 days |
|
|
|
| Secondary | All Cause Mortality | Subjects are considered unevaluable for all cause mortality at 9 months if a) withdrawn before 240 days or b) lost to follow-up before 240 days and had no contact thereafter. | Intent to Treat population | Posted | Number | participants | 9 months |
|
|
|
| 37 |
| 123 |
| 78 |
| 123 |
| CARDIAC DISORDERS | Cardiac disorders | Systematic Assessment |
|
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | General disorders | Systematic Assessment | General disorders and administration site conditions are not stent site disorders/complicatons rather site access point condition due to sheath introduction. |
|
| HEPATOBILIARY DISORDERS | Hepatobiliary disorders | Systematic Assessment |
|
| INFECTIONS AND INFESTATIONS | Infections and infestations | Systematic Assessment |
|
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS | Injury, poisoning and procedural complications | Systematic Assessment |
|
| INVESTIGATIONS | Investigations | Systematic Assessment |
|
| METABOLISM AND NUTRITION DISORDERS | Metabolism and nutrition disorders | Systematic Assessment |
|
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| NERVOUS SYSTEM DISORDERS | Nervous system disorders | Systematic Assessment |
|
| RENAL AND URINARY DISORDERS | Renal and urinary disorders | Systematic Assessment |
|
| REPRODUCTIVE SYSTEM AND BREAST DISORDERS | Reproductive system and breast disorders | Systematic Assessment |
|
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| VASCULAR DISORDERS | Vascular disorders | Systematic Assessment |
|
| GASTROINTESTINAL DISORDERS | Gastrointestinal disorders | Systematic Assessment |
|
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | General disorders | Systematic Assessment |
|
| INFECTIONS AND INFESTATIONS | Infections and infestations | Systematic Assessment |
|
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS | Injury, poisoning and procedural complications | Systematic Assessment |
|
| METABOLISM AND NUTRITION DISORDERS | Metabolism and nutrition disorders | Systematic Assessment |
|
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| NERVOUS SYSTEM DISORDERS | Nervous system disorders | Systematic Assessment |
|
| RENAL AND URINARY DISORDERS | Renal and urinary disorders | Systematic Assessment |
|
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| VASCULAR DISORDERS | Vascular disorders | Systematic Assessment |
|
Medtronic has a legitimate interest in ensuring that a multi-center publication is the first publication to be released regarding the completed Study. The Institution agrees that it will not publish or disclose any results of or information pertaining to the study until a multi-center publication is released. If a publication is not released within one year after completion of the study, the Institution will have the right to publish information pertaining to their activities conducted.