Peripheral Artery Disease
Conditions
Keywords
Iliac Artery Stenting, Peripheral Artery Disease
Brief summary
The purpose of this study is to determine the safety and effectiveness of the Scuba™ 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.
Detailed description
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 SCUBA™ peripheral balloon-expandable cobalt chromium tent system in iliac arteries.
Interventions
DEVICEScuba Iliac Stent System
The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Sponsors
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of de novo or restenotic lesion(s), located in the common or external iliac artery with ≥50% stenosis * Subject has lifestyle limiting claudication or rest pain, (Rutherford- Becker scale \[clinical category\] 2, 3, or 4) * Target vessel reference diameter is 5mm - 10mm by visual assessment * Target lesion length \< 130mm * Subject has angiographic evidence of a patent femoral outflow artery in the target limb * Subject has provided written informed consent * Subject is able and willing to adhere to required follow-up visits and testing
Exclusion criteria
* Subject has lesions in the Common Femoral Artery (CFA), Profundal Femoral Artery (PFA), or Superficial Femoral Artery (SFA) that would require a staged procedure within 30 days of the index procedure (either before or after) * Target lesion(s) has adjacent, acute thrombus * Target lesion(s) is highly calcified or was previously treated with a stent * Subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery * Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion * Subject has a post-surgical stenosis and anastomotic suture treatments in the native iliac vessel * Subject has a vascular graft previously implanted in the native iliac vessel * Subject has tissue loss - Rutherford-Becker clinical category 5 or 6 * History of neutropenia (WBC \<3,000/mm3), coagulopathy, or thrombocytopenia (platelet count \<80,000/uL) * International Normalized ratio (INR) greater than 1.5 * Serum creatinine greater than 2.5 mg/dL * Subject has a known bleeding or hypercoagulability disorder or significant anemia (Hb \< 8.0 g/dL) that cannot be corrected * Subject is participating in an investigational study of a new drug, biologic, or device at the same time of study screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | In-hospital and 9 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | At time of deployment | The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system. |
| Procedural Success | Up to the moment the catheter sheath introducer has been removed | 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). |
| Clinical Success | 30 Days | 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. |
| Patency - Primary | 6 Months | Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months. |
| Patency - Primary Assisted | 6 Months | 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. |
| 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) | 30 Days | 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. |
| Target Limb Revascularization | 9 Months | 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. |
| Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination) | 9 Months | 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. |
| Death | 9 Months | 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. |
| Target Limb Loss | 9 Months | 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. |
| Patency - Secondary | 6 Months | 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. |
Countries
Germany, United States
Participant flow
Recruitment details
Recruitment was for a period of 16 months. Subjects were recruited at medical clinics who participate in clinical trials.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 141 |
| Total | 141 |
Baseline characteristics
| Characteristic | Scuba Iliac Stent System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 56 Participants |
| Age, Categorical Between 18 and 65 years | 85 Participants |
| Age, Continuous | 63.90 years STANDARD_DEVIATION 9.55 |
| Region of Enrollment Germany | 70 participants |
| Region of Enrollment Switzerland | 12 participants |
| Region of Enrollment United States | 59 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 35 / 141 |
| serious Total, serious adverse events | 47 / 141 |
Outcome results
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.
Time frame: In-hospital and 9 Months
Population: Intent to Treat Population (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | 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. | 5.2 Percentage of Participants |
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.
Time frame: 9 Months
Population: Intent to Treat Population (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | Clinical Success | 66.4 Percentage of Patients |
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.
Time frame: 30 Days
Population: Intention to Treat Population (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | Clinical Success | 93.8 Percentage of Patients |
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.
Time frame: 6 Months
Population: Intention to Treat Population (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | Clinical Success | 69.3 Percentage of Patients |
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.
Time frame: 9 Months
Population: Intention to Treat Population (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | Death | 1.5 Percentage of Patients |
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.
Time frame: At time of deployment
Population: Intent to Treat Population (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | Device Success | 95 Percentage of Patients |
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.
Time frame: 30 Days
Population: Intent to Treat Population (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | 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) | 2.2 Percentage of Patients |
Secondary
Patency - Primary
Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months.
Time frame: 6 Months
Population: Intention to Treat Population (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | Patency - Primary | 94.9 Percentage of Patients |
Secondary
Patency - Primary
Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 9 months.
Time frame: 9 Months
Population: Intention to Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | Patency - Primary | 95.3 Percentage of Patients |
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.
Time frame: 9 Months
Population: Intention to Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | Patency - Primary Assisted | 1.9 Percentage of Patients |
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.
Time frame: 6 Months
Population: Intention to Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | Patency - Primary Assisted | 1.5 Percentage of Patients |
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.
Time frame: 6 Months
Population: Intention to Treat Population (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | Patency - Secondary | 3.7 Percentage of Patients |
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.
Time frame: 9 Months
Population: Intention to Treat Population (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | Patency - Secondary | 1.9 Percentage of Patients |
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).
Time frame: Up to the moment the catheter sheath introducer has been removed
Population: Intention to Treat Population (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | Procedural Success | 86.5 Percentage of Patients |
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.
Time frame: 9 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination) | 1.9 Percentage of Patients |
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.
Time frame: 9 Months
Population: Intention to Treat Population (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | Target Limb Loss | 0 Percentage of Patients |
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.
Time frame: 9 Months
Population: Intention to Treat Population (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scuba Iliac Stent System | Target Limb Revascularization | 7.5 Percentage of Patients |