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The purpose of this study is to determine the safety and effectiveness of the Scubaâ„¢ stent in subjects with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery.
Interventional revascularization strategies for peripheral arterial disease currently available include both surgical and endovascular approaches such as percutaneous transluminal angioplasty (PTA), either as a stand-alone procedure or with the placement of a stent. Cobalt-chromium (CoCr) is an alloy that has been used safely in the manufacture of surgical implants for use in contact with blood, soft tissue and bone for over 10 years. This study will evaluate the SCUBAâ„¢ peripheral balloon-expandable cobalt chromium tent system in iliac arteries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scuba Iliac Stent System | Experimental | Device: Scubaâ„¢ iliac stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scuba Iliac Stent System | Device | The Scubaâ„¢ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Major Adverse Events (MAE) Defined as the Occurrence of In-hospital Myocardial Infarction (MI) or Target Segment Revascularization, Target Limb Loss, or Death Within 9 Months Post-procedure. | The analysis is based on the percentage of Intent to Treat subjects (ITT) who experienced the primary endpoint or who had adequate follow-up for the 9-month analysis. A subject had adequate follow-up if he/she had an event or had a follow-up of at least 256 days, allowing for a visit window of 9 months +/- 14 days. | In-hospital and 9 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Vascular Events Through 30 Days as a Composite of (MI, Death or Stroke, Stent Thrombosis, Distal Embolization, Arterial Rupture/Perforation, Acute Limb Ischemia, Target Limb Loss, Procedure-related Bleeding Event Requiring Transfusion) | The analysis is based on the number of patients who experienced either an MI, died, had a stroke, stent thrombosis, distal embolization, arterial rupture/perforation limb ischemia, lost a target limb, or had a bleeding event due to the procedure within 30 days after being treated with the Scuba iliac stent. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce H Gray, DO | Greeville Health System | Principal Investigator |
| Barry T Katzen, MD | Baptist Health South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States | ||
| Greenville Hospital System |
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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 | Scuba Iliac Stent System | Device: Scuba Iliac Stent Scuba Iliac Stent System: The Scuba Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Scuba Iliac Stent System | Device: Scubaâ„¢ Iliac stent Scuba Iliac Stent System: The Scubaâ„¢ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Composite of Major Adverse Events (MAE) Defined as the Occurrence of In-hospital Myocardial Infarction (MI) or Target Segment Revascularization, Target Limb Loss, or Death Within 9 Months Post-procedure. | The analysis is based on the percentage of Intent to Treat subjects (ITT) who experienced the primary endpoint or who had adequate follow-up for the 9-month analysis. A subject had adequate follow-up if he/she had an event or had a follow-up of at least 256 days, allowing for a visit window of 9 months +/- 14 days. | Intent to Treat Population (ITT) | Posted | Number | Percentage of Participants | In-hospital and 9 Months |
|
From subject index procedure through the 9 month follow-up visit period.
In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
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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 | Scuba Iliac Stent System | Device: Scubaâ„¢ iliac stent Scuba Iliac Stent System : The Scubaâ„¢ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Coronary Syndrome | Cardiac disorders | MedDRA (11.0) | 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 |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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|
| 30 Days |
| Device Success | The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system. | At time of deployment |
| Procedural Success | The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system [Device Success] and the achievement of <30% residual stenosis immediately after stent deployment, without occurrence of in-hospital Major Adverse Events (MAE). | Up to the moment the catheter sheath introducer has been removed |
| Clinical Success | Early Clinical Success (30 days) is defined as improvement of the Rutherford-Becker scale criteria by greater than or equal to one category as obtained at the 30 day follow-up visit. | 30 Days |
| Clinical Success | Late Clinical Success (6 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success. | 6 Months |
| Clinical Success | Late Clinical Success (9 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success. | 9 Months |
| Patency - Primary | Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months. | 6 Months |
| Patency - Primary Assisted | Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 6 months. | 6 Months |
| Patency - Secondary | Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 6 months. | 6 Months |
| Patency - Primary | Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 9 months. | 9 Months |
| Patency - Primary Assisted | Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 9 months. | 9 Months |
| Patency - Secondary | Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 9 months. | 9 Months |
| Target Limb Revascularization | Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery. | 9 Months |
| Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination) | Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery. | 9 Months |
| Death | Death can be classified as one of three categories: cardiac, vascular, or non-cardiovascular. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. | 9 Months |
| Target Limb Loss | Amputation of the target limb by surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target segment. Amputations are subclassified as: Above the knee, Below the knee, Transmetatarsal, and Toe. | 9 Months |
| Greenville |
| South Carolina |
| 29605 |
| United States |
| Hamburg University Cardiovascular Center | Hamburg | 22527 | Germany |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Major Adverse Vascular Events Through 30 Days as a Composite of (MI, Death or Stroke, Stent Thrombosis, Distal Embolization, Arterial Rupture/Perforation, Acute Limb Ischemia, Target Limb Loss, Procedure-related Bleeding Event Requiring Transfusion) | The analysis is based on the number of patients who experienced either an MI, died, had a stroke, stent thrombosis, distal embolization, arterial rupture/perforation limb ischemia, lost a target limb, or had a bleeding event due to the procedure within 30 days after being treated with the Scuba iliac stent. | Intent to Treat Population (ITT) | Posted | Number | Percentage of Patients | 30 Days |
|
|
|
| Secondary | Device Success | The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system. | Intent to Treat Population (ITT) | Posted | Number | Percentage of Patients | At time of deployment |
|
|
|
| Secondary | Procedural Success | The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system [Device Success] and the achievement of <30% residual stenosis immediately after stent deployment, without occurrence of in-hospital Major Adverse Events (MAE). | Intention to Treat Population (ITT) | Posted | Number | Percentage of Patients | Up to the moment the catheter sheath introducer has been removed |
|
|
|
| Secondary | Clinical Success | Early Clinical Success (30 days) is defined as improvement of the Rutherford-Becker scale criteria by greater than or equal to one category as obtained at the 30 day follow-up visit. | Intention to Treat Population (ITT) | Posted | Number | Percentage of Patients | 30 Days |
|
|
|
| Secondary | Clinical Success | Late Clinical Success (6 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success. | Intention to Treat Population (ITT) | Posted | Number | Percentage of Patients | 6 Months |
|
|
|
| Secondary | Clinical Success | Late Clinical Success (9 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success. | Intent to Treat Population (ITT) | Posted | Number | Percentage of Patients | 9 Months |
|
|
|
| Secondary | Patency - Primary | Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months. | Intention to Treat Population (ITT) | Posted | Number | Percentage of Patients | 6 Months |
|
|
|
| Secondary | Patency - Primary Assisted | Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 6 months. | Intention to Treat (ITT) | Posted | Number | Percentage of Patients | 6 Months |
|
|
|
| Secondary | Patency - Secondary | Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 6 months. | Intention to Treat Population (ITT) | Posted | Number | Percentage of Patients | 6 Months |
|
|
|
| Secondary | Patency - Primary | Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 9 months. | Intention to Treat (ITT) | Posted | Number | Percentage of Patients | 9 Months |
|
|
|
| Secondary | Patency - Primary Assisted | Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 9 months. | Intention to Treat (ITT) | Posted | Number | Percentage of Patients | 9 Months |
|
|
|
| Secondary | Patency - Secondary | Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 9 months. | Intention to Treat Population (ITT) | Posted | Number | Percentage of Patients | 9 Months |
|
|
|
| Secondary | Target Limb Revascularization | Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery. | Intention to Treat Population (ITT) | Posted | Number | Percentage of Patients | 9 Months |
|
|
|
| Secondary | Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination) | Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery. | Posted | Number | Percentage of Patients | 9 Months |
|
|
|
| Secondary | Death | Death can be classified as one of three categories: cardiac, vascular, or non-cardiovascular. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. | Intention to Treat Population (ITT) | Posted | Number | Percentage of Patients | 9 Months |
|
|
|
| Secondary | Target Limb Loss | Amputation of the target limb by surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target segment. Amputations are subclassified as: Above the knee, Below the knee, Transmetatarsal, and Toe. | Intention to Treat Population (ITT) | Posted | Number | Percentage of Patients | 9 Months |
|
|
|
| 47 |
| 141 |
| 35 |
| 141 |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Angina Unstable | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrial Fibrilation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary Artery Stenosis | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (11.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gastric Ulcer | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gastritis Erosive | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Catheter Site Haemorrhage | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Tenderness | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Post Procedural Infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| In-stent Arterial Restenosis | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Meniscus Lesion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Stent Occlusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Thrombus in Device | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cervical Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Breast Cancer Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Oesophageal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Carotid Artery Stenosis | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Bipolar Disorder | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Calculus Ureteric | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Renal Artery Stenosis | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aortic Aneurysm | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arterial Thrombus Limb | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Femoral Arterial Stenosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypertensive Emergency | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Iliac Artery Occlusion | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Iliac Artery Stenosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Iliac Artery Thrombosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Intermittent Claudication | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Leriche Syndrome | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral Artery Dissection | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral Embolism | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral Ischaemia | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Subclavian Artery Stenosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Catheter Site Haematoma | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Femoral Artery Stenosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Intermittent Claudication | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral Artery Dissection | Vascular disorders | MedDRA (11.0) | 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.
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |