Peripheral Vascular DiseaseNCT00814970
The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions
A study testing Complete SE Vascular Stent System in people with Peripheral Vascular Disease, run by Medtronic Endovascular at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Complete SE Vascular Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2008to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
AnMed Health
Anderson, South Carolina, 29621
Washington Hospital
Fremont, California, 94538
N. Florida Regional Medical Center
Gainesville, Florida, 32605
Munroe Regional Medical Center
Ocala, Florida, 34478
About this study
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
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).
Read the 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.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Complete SE Vascular Stent System
- Keywords
- PAD, peripheral arterial disease, stent, SFA, PPA
- Medical subject headings
- Peripheral Vascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete SE Vascular Stent SystemDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Complete SE Vascular Stent System | Experimental | 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. Receives: Device: Complete SE Vascular Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
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).
Measured: 12 Months
Secondary outcomes (16)
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.
Measured: 30 days
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.
Measured: 6 Months
Device Success
The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.
Measured: At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).
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.
Measured: At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).
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.
Measured: At time of deployment to time of hospital discharge
Assisted Primary Patency
Defined as vessel patency resulting from a procedure performed in the treated segment.
Measured: 12 months
Secondary Patency Rate
Defined as vessel patency resulting from any procedure that restores patency.
Measured: 12 Months
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).
Measured: 12 months
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.
Measured: 12 Months
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).
Measured: 30 Days
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.
Measured: 12 Months
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
Measured: 12 Months
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.
Measured: 24 Months
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.
Measured: 24 Months
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.
Measured: 36 Months
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.
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Laird, MD, Principal investigator, University of California, DavisDierk Scheinert, PD, Principal investigator, Park-Krankenhaus Leipzig-Sudost GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814970
- Sponsor's protocol ID
- IP105
- Other IDs
- IDE G080143
- Status last verified
- Feb 2016
- First submitted
- 23 Dec 2008
- Last updated
- 13 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24754279
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00814970
- Acronym / sponsor ID
- IP105
- Conditions
- Peripheral Vascular Disease
- Keywords
- PAD, peripheral arterial disease, stent, SFA, PPA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Dec 2008 (estimated)
- Results
- Posted 21 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complete SE Vascular Stent System | Experimental | Device: Complete SE Vascular Stent SystemCOMPLETE 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete SE Vascular Stent SystemComplete 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). | Device | Complete SE Vascular Stent System |
Primary outcome
Major Adverse Event (MAE) Rate
Time frame: 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
Time frame: 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).
16 secondary outcomes
Major Adverse Event (MAE) Rate
Time frame: 30 days
Major Adverse Event (MAE) Rate
Time frame: 6 Months
Device Success
Time frame: At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).
Lesion Success
Time frame: At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).
Procedure Success
Time frame: At time of deployment to time of hospital discharge
Assisted Primary Patency
Time frame: 12 months
Secondary Patency Rate
Time frame: 12 Months
Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category
Time frame: 12 months
Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15
Time frame: 12 Months
Change in Quality of Life - Decrease in Rutherford Class >= 1 Category
Time frame: 30 Days
Percentage of Participants Free From Strut Fractures
Time frame: 12 Months
Clinically-driven Target Lesion Revascularization (TLR) Rate
Time frame: 12 Months
Major Adverse Event (MAE) Rate
Time frame: 24 Months
Percentage of Participants Free From Strut Fractures
Time frame: 24 Months
Major Adverse Event (MAE) Rate
Time frame: 36 Months
Percentage of Participants Free From Strut Fractures
Time frame: 36 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24754279Laird 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Laird, MD principal investigator
University of California, Davis
Dierk Scheinert, PD principal investigator
Park-Krankenhaus Leipzig-Sudost GmbH
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete SE Vascular Stent System in people with Peripheral Vascular Disease, run by Medtronic Endovascular at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Event (MAE) Rate (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00814970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.