CompletedNCT00814970Updated Apr 13, 2016Results posted

The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions

An interventional study of Complete SE Vascular Stent System in Peripheral Vascular Disease, sponsored by Medtronic Endovascular. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-13.

Sponsored by Medtronic Endovascular (part of Medtronic) · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 196
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Peripheral Vascular Disease

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Keywords

PAD
peripheral arterial disease
stent
SFA
PPA

In context

Peripheral Vascular Diseases

1,025 studies on the registry are indexed under Peripheral Vascular Diseases; 123 are open to participants now.

This study's enrollment of 196 is above the median of 70 across 729 interventional studies indexed under Peripheral Vascular Diseases.

Browse Peripheral Vascular Diseases studies →

Lead sponsor

Medtronic Endovascular is the lead sponsor of 51 studies on the registry; 3 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Browse Medtronic Endovascular studies →All Medtronic studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 196 participants (actual)

Study arms

Experimental
Complete SE Vascular Stent System
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.
Device: Complete SE Vascular Stent System

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).

What researchers measure

Primary outcomes

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
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

Secondary outcomes

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
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
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).
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).
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
Assisted Primary Patency
Defined as vessel patency resulting from a procedure performed in the treated segment.
Time frame: 12 months
Secondary Patency Rate
Defined as vessel patency resulting from any procedure that restores patency.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 36 Months

Results

Posted May 21, 2014

Participant flow

Recruitment was for a period of 20 months. Subjects were recruited at medical clinics who participate in clinical trials.

Participant flow — Overall Study
Milestone	Complete Self-expanding (SE) Vascular Stent System
Started	196
Completed	146
Not completed	50

Outcome measures

PrimaryMajor 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
Reported as:: Number · percentage of participants

Major Adverse Event (MAE) Rate
percentage of participants	Complete SE Vascular Stent System
Major Adverse Event (MAE) Rate	11.0

PrimaryPrimary 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
Reported as:: Number · percentage of participants

Primary Patency Rate
percentage of participants	Complete SE Vascular Stent System
Primary Patency Rate	72.6

SecondaryMajor Adverse Event (MAE) Rate

Time frame:: 30 days
Reported as:: Number · percentage of participants

Major Adverse Event (MAE) Rate
percentage of participants	Complete SE Vascular Stent System
Major Adverse Event (MAE) Rate	0.5

SecondaryMajor Adverse Event (MAE) Rate

Time frame:: 6 Months
Reported as:: Number · percentage of participants

Major Adverse Event (MAE) Rate
percentage of participants	Complete SE Vascular Stent System
Major Adverse Event (MAE) Rate	4.1

SecondaryDevice 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).
Reported as:: Number · percentage of lesions treated

Device Success
percentage of lesions treated	Complete SE Vascular Stent System
Device Success	90.0

SecondaryLesion 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).
Reported as:: Number · percentage of lesions treated

Lesion Success
percentage of lesions treated	Complete SE Vascular Stent System
Lesion Success	90.0

SecondaryProcedure 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
Reported as:: Number · percentage of lesions treated

Procedure Success
percentage of lesions treated	Complete SE Vascular Stent System
Procedure Success	89.1

SecondaryAssisted Primary Patency

Defined as vessel patency resulting from a procedure performed in the treated segment.

Time frame:: 12 months
Reported as:: Number · percentage of participants

Assisted Primary Patency
percentage of participants	Complete SE Vascular Stent System
Assisted Primary Patency	78.3

SecondarySecondary Patency Rate

Defined as vessel patency resulting from any procedure that restores patency.

Time frame:: 12 Months
Reported as:: Number · percentage of participants

Secondary Patency Rate
percentage of participants	Complete SE Vascular Stent System
Secondary Patency Rate	78.9

SecondaryChange 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
Reported as:: Number · percentage of participants

Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category
percentage of participants	Complete SE Vascular Stent System
Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category	90.9

SecondaryChange 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
Reported as:: Number · percentage of participants

Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15
percentage of participants	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

SecondaryChange 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
Reported as:: Number · percentage of participants

Change in Quality of Life - Decrease in Rutherford Class >= 1 Category
percentage of participants	Complete SE Vascular Stent System
Change in Quality of Life - Decrease in Rutherford Class >= 1 Category	89.7

SecondaryPercentage 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
Reported as:: Number · percentage of participants

Percentage of Participants Free From Strut Fractures
percentage of participants	Complete SE Vascular Stent System
Percentage of Participants Free From Strut Fractures	100.0

SecondaryClinically-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
Reported as:: Number · percentage of participants

Clinically-driven Target Lesion Revascularization (TLR) Rate
percentage of participants	Complete SE Vascular Stent System
Clinically-driven Target Lesion Revascularization (TLR) Rate	8.4

SecondaryMajor Adverse Event (MAE) Rate

Time frame:: 24 Months
Reported as:: Number · percentage of participants

Major Adverse Event (MAE) Rate
percentage of participants	Complete SE Vascular Stent System
Major Adverse Event (MAE) Rate	22.5

SecondaryPercentage 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
Reported as:: Number · percentage of participants

Percentage of Participants Free From Strut Fractures
percentage of participants	Complete Self-expanding (SE) Vascular Stent System
Percentage of Participants Free From Strut Fractures	100.0

SecondaryMajor Adverse Event (MAE) Rate

Time frame:: 36 Months
Reported as:: Number · percentage of participants

Major Adverse Event (MAE) Rate
percentage of participants	Complete SE Vascular Stent System
Major Adverse Event (MAE) Rate	30.2

SecondaryPercentage 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
Reported as:: Number · percentage of participants

Percentage of Participants Free From Strut Fractures
percentage of participants	Complete SE Vascular Stent System
Percentage of Participants Free From Strut Fractures	100.0

Adverse events

Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
1. Complete SE Vascular Stent System	—	117/196 (59.7%)	50/196 (25.5%)

Most frequent serious events

Showing 10 of 116

Most frequent serious events
Event	1. Complete SE Vascular Stent System
Femoral Arterial StenosisVascular disorders	16/196
In-Stent Arterial RestenosisInjury, poisoning and procedural complications	14/196
Intermittent ClaudicationVascular disorders	13/196
Coronary Artery DiseaseCardiac disorders	10/196
Chest PainGeneral disorders	9/196
AnaemiaBlood and lymphatic system disorders	8/196
Carotid Artery StenosisNervous system disorders	7/196
Artery DissectionVascular disorders	7/196
PneumoniaInfections and infestations	5/196
SepsisInfections and infestations	5/196

Most frequent other events

Most frequent other events
Event	1. Complete SE Vascular Stent System
Intermittent ClaudicationVascular disorders	17/196
Back PainMusculoskeletal and connective tissue disorders	16/196
Pain In ExtremityMusculoskeletal and connective tissue disorders	15/196
Chest PainGeneral disorders	12/196

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Complete SE Vascular Stent System
<=18 years	0
Between 18 and 65 years	74
>=65 years	122

Age, Continuous
Age, Continuous(years)	Complete SE Vascular Stent System
Mean	68.7 ± 10.5

Sex: Female, Male
Sex: Female, Male(Participants)	Complete SE Vascular Stent System
Female	72
Male	124

Region of Enrollment
Region of Enrollment(participants)	Complete SE Vascular Stent System
United States	133
Germany	48
Belgium	15

Study locations

4 sites

Washington Hospital
Fremont, California 94538, United States
N. Florida Regional Medical Center
Gainesville, Florida 32605, United States
Munroe Regional Medical Center
Ocala, Florida 34478, United States
AnMed Health
Anderson, South Carolina 29621, United States

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00814970
Lead sponsor: Medtronic Endovascular
Responsible party: Sponsor
First posted: Dec 25, 2008
Start date: Nov 2008
Primary completion: Sep 2011
Completion: Dec 2013
Results posted: May 21, 2014
Last update: Apr 13, 2016

Study contacts

John Laird, MD

principal investigator · University of California, Davis

Dierk Scheinert, PD

principal investigator · Park-Krankenhaus Leipzig-Sudost GmbH

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions

Study summary

Conditions studied

Browse trials for

Keywords

In context

Peripheral Vascular Diseases

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria