Back to resultsThe Complete® SE SFA Study for the Treatment of SFA/PPA Lesions
Primary Purpose
Peripheral Vascular Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Complete SE Vascular Stent System
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vascular Disease focused on measuring PAD, peripheral arterial disease, stent, SFA, PPA
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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;
- Target vessel reference diameter is ≥4.0 mm and ≤7.0 mm (visual estimate);
- Target lesion length is ≥4.0 cm and ≤14.0 cm (visual estimate);
- Adequate distal run-off to the ankle in the target limb (defined as having at least one patent calf vessel <50% stenosed;
Life expectancy >12 months.
Exclusion Criteria:
- Women who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment;
- 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;
- Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
- 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;
- Target lesion located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion;
- 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);
- History of bleeding diatheses or coagulopathy or will refuse blood transfusions;
- Known impaired renal function, defined as creatinine >2.5 mg/dl;
- Known platelet count <80,000 cells/mm3 or >700,000 cells/mm3;
- Known white blood cell (WBC) of <3,000 cells/mm3;
- 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.
Sites / Locations
- Washington Hospital
- N. Florida Regional Medical Center
- Munroe Regional Medical Center
- AnMed Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Complete SE Vascular Stent System
Arm Description
COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
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.
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.
Device Success
The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.
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.
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.
Assisted Primary Patency
Defined as vessel patency resulting from a procedure performed in the treated segment.
Secondary Patency Rate
Defined as vessel patency resulting from any procedure that restores patency.
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).
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.
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).
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.
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
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.
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.
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.
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.
Full Information
NCT ID
NCT00814970
First Posted
December 23, 2008
Last Updated
March 14, 2016
Sponsor
Medtronic Endovascular
1. Study Identification
Unique Protocol Identification Number
NCT00814970
Brief Title
The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions
Official Title
The Complete® SE SFA Study: The Medtronic Complete Self-Expanding SFA Stent System for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and/or Proximal Popliteal Arteries
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease
Keywords
PAD, peripheral arterial disease, stent, SFA, PPA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Complete SE Vascular Stent System
Arm Type
Experimental
Arm Description
COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.
Intervention Type
Device
Intervention Name(s)
Complete SE Vascular Stent System
Intervention Description
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).
Primary Outcome Measure Information:
Title
Major Adverse Event (MAE) Rate
Description
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
Title
Primary Patency Rate
Description
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
Secondary Outcome Measure Information:
Title
Major Adverse Event (MAE) Rate
Description
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
Title
Major Adverse Event (MAE) Rate
Description
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
Title
Device Success
Description
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).
Title
Lesion Success
Description
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).
Title
Procedure Success
Description
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
Title
Assisted Primary Patency
Description
Defined as vessel patency resulting from a procedure performed in the treated segment.
Time Frame
12 months
Title
Secondary Patency Rate
Description
Defined as vessel patency resulting from any procedure that restores patency.
Time Frame
12 Months
Title
Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category
Description
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
Title
Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15
Description
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
Title
Change in Quality of Life - Decrease in Rutherford Class >= 1 Category
Description
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
Title
Percentage of Participants Free From Strut Fractures
Description
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
Title
Clinically-driven Target Lesion Revascularization (TLR) Rate
Description
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
Title
Major Adverse Event (MAE) Rate
Description
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
Title
Percentage of Participants Free From Strut Fractures
Description
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
Title
Major Adverse Event (MAE) Rate
Description
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
Title
Percentage of Participants Free From Strut Fractures
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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;
Target vessel reference diameter is ≥4.0 mm and ≤7.0 mm (visual estimate);
Target lesion length is ≥4.0 cm and ≤14.0 cm (visual estimate);
Adequate distal run-off to the ankle in the target limb (defined as having at least one patent calf vessel <50% stenosed;
Life expectancy >12 months.
Exclusion Criteria:
Women who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment;
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;
Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
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;
Target lesion located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion;
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);
History of bleeding diatheses or coagulopathy or will refuse blood transfusions;
Known impaired renal function, defined as creatinine >2.5 mg/dl;
Known platelet count <80,000 cells/mm3 or >700,000 cells/mm3;
Known white blood cell (WBC) of <3,000 cells/mm3;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Laird, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dierk Scheinert, PD
Organizational Affiliation
Park-Krankenhaus Leipzig-Sudost GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Hospital
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
N. Florida Regional Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Munroe Regional Medical Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34478
Country
United States
Facility Name
AnMed Health
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24754279
Citation
Laird JR, Jain A, Zeller T, Feldman R, Scheinert D, Popma JJ, Armstrong EJ, Jaff MR; Complete SE Investigators. Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: twelve-month results from the complete SE multicenter trial. J Endovasc Ther. 2014 Apr;21(2):202-12. doi: 10.1583/13-4548R.1.
Results Reference
derived
Learn more about this trial
The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions
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