Peripheral Vascular Disease
Conditions
Keywords
PAD, peripheral arterial disease, stent, SFA, PPA
Brief summary
To evaluate the safety and efficacy of the Complete SE SFA Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).
Detailed description
The Complete Self-Expanding (SE) SFA Stent is designed to be a permanent implant. It is cut from a nickel titanium alloy (Nitinol) tube and consists of a series of segments each connected to the next in a unique pattern to allow for flexibility and vessel conformability. Each segment consists of two struts and a crown (Figure 1). It is designed to produce optimal luminal diameter and increased scaffolding, and to maintain luminal patency.
Interventions
DEVICEComplete SE Vascular Stent System
Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).
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
1. Rutherford 2-4, with an occlusion or de novo and/or restenotic SFA/PPA lesion ≥50% and ankle-brachial index/toe-brachial index (ABI/TBI) \<0.90/0.80. 2. Target lesion located at least 1 cm distal to the take-off of the profunda femoris artery and at least 3 cm proximal to the highest point of the cortical margin of the femur; 3. Target vessel reference diameter is ≥4.0 mm and ≤7.0 mm (visual estimate); 4. Target lesion length is ≥4.0 cm and ≤14.0 cm (visual estimate); 5. Adequate distal run-off to the ankle in the target limb (defined as having at least one patent calf vessel \<50% stenosed; 6. Life expectancy \>12 months.
Exclusion criteria
7. Women who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment; 8. Any condition that precludes safe access with percutaneous transluminal angioplasty (PTA) devices, such as: excessive peripheral artery disease, unresolved fresh thrombus in the target lesion/vessel, or a target lesion/vessel that is excessively tortuous or calcified; 9. Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure; 10. Previous treatment to the target lesion within the 3 months prior to enrollment; previous femoropopliteal bypass in target vessel; previous stenting of the target lesion; 11. Target lesion located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion; 12. Target lesion requires treatment other than standard PTA prior to stent placement (i.e., no other devices or procedures such as cutting balloons and laser atherectomy are permitted to be used during the index procedure); 13. History of bleeding diatheses or coagulopathy or will refuse blood transfusions; 14. Known impaired renal function, defined as creatinine \>2.5 mg/dl; 15. Known platelet count \<80,000 cells/mm3 or \>700,000 cells/mm3; 16. Known white blood cell (WBC) of \<3,000 cells/mm3; 17. Participation in another investigational device or drug study and has not completed the primary endpoint(s) or which clinically interferes with the Complete SE SFA Study endpoints, or previously enrolled in the Complete SE SFA Study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Event (MAE) Rate | 12 Months | Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization. |
| Primary Patency Rate | 12 Months | Primary patency defined as uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥ 50% as documented by peak systolic velocity ratio ≥2.0 as assessed by duplex ultrasound (DUS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Success | At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient). | The outcome is based on the angiographic evidence of \<30% final residual stenosis of the target lesion using either the Complete SE SFA Stent System or other standard percutaneous devices. |
| Procedure Success | At time of deployment to time of hospital discharge | The outcome is based on the angiographic evidence of \<30% final residual stenosis of the target lesion after stent implantation and no occurrence of a procedure-related Major Adverse Events (MAE) prior to hospital discharge. |
| Assisted Primary Patency | 12 months | Defined as vessel patency resulting from a procedure performed in the treated segment. |
| Secondary Patency Rate | 12 Months | Defined as vessel patency resulting from any procedure that restores patency. |
| Major Adverse Event (MAE) Rate | 30 days | Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 30 day timepoint. |
| Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15 | 12 Months | Increase in ABI/TBI ≥ 0.15 at 12 months from pre-procedure. An increase in ABI/TBI of 0.15 or greater is considered by clinicians to be a significant improvement. |
| Change in Quality of Life - Decrease in Rutherford Class >= 1 Category | 30 Days | Decline in Rutherford class ≥ 1 category at 30 days when compared to pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms). |
| Percentage of Participants Free From Strut Fractures | 12 Months | Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up. |
| Clinically-driven Target Lesion Revascularization (TLR) Rate | 12 Months | Defined as those revascularizations in which the subject has ischemic symptoms consistent with changes within the target lesion as demonstrated by: a change (decrease from post-procedure) in the Rutherford scale by at least one category, or a change (decrease from post-procedure) in ABI/TBI \>= 0.15 |
| Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category | 12 months | Improvement in Rutherford class by ≥ 1 category increase at 12 months from pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms). |
| Device Success | At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient). | The outcome is based on the angiographic evidence of \<30% final residual stenosis of the target lesion using only the assigned device. |
Countries
United States
Participant flow
Recruitment details
Recruitment was for a period of 20 months. Subjects were recruited at medical clinics who participate in clinical trials.
Participants by arm
| Arm | Count |
|---|---|
| Complete SE Vascular Stent System Device: Complete SE Vascular Stent System\>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system. | 196 |
| Total | 196 |
Baseline characteristics
| Characteristic | Complete SE Vascular Stent System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 122 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants |
| Age, Continuous | 68.7 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment Belgium | 15 participants |
| Region of Enrollment Germany | 48 participants |
| Region of Enrollment United States | 133 participants |
| Sex: Female, Male Female | 72 Participants |
| Sex: Female, Male Male | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 50 / 196 |
| serious Total, serious adverse events | 117 / 196 |
Outcome results
Primary
Major Adverse Event (MAE) Rate
Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization.
Time frame: 12 Months
Population: Intent-to-Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Major Adverse Event (MAE) Rate | 11.0 percentage of participants |
Primary
Primary Patency Rate
Primary patency defined as uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥ 50% as documented by peak systolic velocity ratio ≥2.0 as assessed by duplex ultrasound (DUS).
Time frame: 12 Months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Primary Patency Rate | 72.6 percentage of participants |
Secondary
Assisted Primary Patency
Defined as vessel patency resulting from a procedure performed in the treated segment.
Time frame: 12 months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Assisted Primary Patency | 78.3 percentage of participants |
Secondary
Change in Quality of Life - Decrease in Rutherford Class >= 1 Category
Decline in Rutherford class ≥ 1 category at 30 days when compared to pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).
Time frame: 30 Days
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Change in Quality of Life - Decrease in Rutherford Class >= 1 Category | 89.7 percentage of participants |
Secondary
Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category
Improvement in Rutherford class by ≥ 1 category increase at 12 months from pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).
Time frame: 12 months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category | 90.9 percentage of participants |
Secondary
Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15
Increase in ABI/TBI ≥ 0.15 at 12 months from pre-procedure. An increase in ABI/TBI of 0.15 or greater is considered by clinicians to be a significant improvement.
Time frame: 12 Months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15 | 64.5 percentage of participants |
Secondary
Clinically-driven Target Lesion Revascularization (TLR) Rate
Defined as those revascularizations in which the subject has ischemic symptoms consistent with changes within the target lesion as demonstrated by: a change (decrease from post-procedure) in the Rutherford scale by at least one category, or a change (decrease from post-procedure) in ABI/TBI \>= 0.15
Time frame: 12 Months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Clinically-driven Target Lesion Revascularization (TLR) Rate | 8.4 percentage of participants |
Secondary
Device Success
The outcome is based on the angiographic evidence of \<30% final residual stenosis of the target lesion using only the assigned device.
Time frame: At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Device Success | 90.0 percentage of lesions treated |
Secondary
Lesion Success
The outcome is based on the angiographic evidence of \<30% final residual stenosis of the target lesion using either the Complete SE SFA Stent System or other standard percutaneous devices.
Time frame: At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Lesion Success | 90.0 percentage of lesions treated |
Secondary
Major Adverse Event (MAE) Rate
Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 30 day timepoint.
Time frame: 30 days
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Major Adverse Event (MAE) Rate | 0.5 percentage of participants |
Secondary
Major Adverse Event (MAE) Rate
Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 6 month timepoint.
Time frame: 6 Months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Major Adverse Event (MAE) Rate | 4.1 percentage of participants |
Secondary
Major Adverse Event (MAE) Rate
Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 24 month timepoint.
Time frame: 24 Months
Population: Intention-to-Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Major Adverse Event (MAE) Rate | 22.5 percentage of participants |
Secondary
Major Adverse Event (MAE) Rate
Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 36 month timepoint.
Time frame: 36 Months
Population: Intention-to-Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Major Adverse Event (MAE) Rate | 30.2 percentage of participants |
Secondary
Percentage of Participants Free From Strut Fractures
Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 36 month timepoint.
Time frame: 36 Months
Population: Intention-to-Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Percentage of Participants Free From Strut Fractures | 100.0 percentage of participants |
Secondary
Percentage of Participants Free From Strut Fractures
Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 24 month timepoint.
Time frame: 24 Months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Percentage of Participants Free From Strut Fractures | 100.0 percentage of participants |
Secondary
Percentage of Participants Free From Strut Fractures
Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up.
Time frame: 12 Months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Percentage of Participants Free From Strut Fractures | 100.0 percentage of participants |
Secondary
Procedure Success
The outcome is based on the angiographic evidence of \<30% final residual stenosis of the target lesion after stent implantation and no occurrence of a procedure-related Major Adverse Events (MAE) prior to hospital discharge.
Time frame: At time of deployment to time of hospital discharge
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Procedure Success | 89.1 percentage of lesions treated |
Secondary
Secondary Patency Rate
Defined as vessel patency resulting from any procedure that restores patency.
Time frame: 12 Months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Vascular Stent System | Secondary Patency Rate | 78.9 percentage of participants |