The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions - Full Text View

Sponsor:	Medtronic Endovascular
Information provided by (Responsible Party):	Medtronic Endovascular
ClinicalTrials.gov Identifier:	NCT00814970

Purpose

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).

Condition	Intervention
Peripheral Vascular Disease	Device: Complete Self-Expanding SFA Stent System

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

U.S. FDA Resources

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:

MAE and Primary Patency Rates [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

MAE rate [ Time Frame: 30 days, 6 months, 24 months, 36 months ] [ Designated as safety issue: Yes ]
Assisted primary patency [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Stent integrity [ Time Frame: 6, 12, 24, 36 Months ] [ Designated as safety issue: Yes ]
Acute success (device, lesion, procedure) [ Time Frame: post procedure ] [ Designated as safety issue: Yes ]
Change in quality of life [ Time Frame: 36 months ] [ Designated as safety issue: No ]
All-cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	196
Study Start Date:	November 2008
Estimated Study Completion Date:	June 2013
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Implantation of study device in native SFA and/or PPA	Device: Complete Self-Expanding SFA Stent System Self-expanding, nitinol stent

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Rutherford 2-4, with an occlusion or de novo and/or restenotic SFA/PPA lesion ≥50% and 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 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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814970

Locations

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

Sponsors and Collaborators

Medtronic Endovascular

Investigators

Principal Investigator:	John Laird, MD	University of California, Davis
Principal Investigator:	Dierk Scheinert, PD	Park-Krankenhaus Leipzig-Sudost GmbH

More Information

No publications provided

Responsible Party:	Medtronic Endovascular
ClinicalTrials.gov Identifier:	NCT00814970 History of Changes
Other Study ID Numbers:	IP105
Study First Received:	December 23, 2008
Last Updated:	January 25, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:

PAD
peripheral arterial disease
stent
SFA
PPA

Additional relevant MeSH terms:

Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases

Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on February 09, 2012