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

NCT00814970 | Completed Results DMC

• 2 other identifiers: IP105IDE G080143
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 4

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).

Conditions

Peripheral Vascular Disease

Keywords

PAD; peripheral arterial disease; stent; SFA; PPA

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  12 Months

Secondary Outcomes (16)

• Major Adverse Event (MAE) Rate

  30 days

• Major Adverse Event (MAE) Rate

  6 Months

• Device Success

  At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).

• Lesion Success

  At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).

• Procedure Success

  At time of deployment to time of hospital discharge

Study Arms (1)

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.

Device: Complete SE Vascular Stent System

Interventions

Complete SE Vascular Stent System DEVICE

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).

Complete SE Vascular Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (4)

Washington Hospital

Fremont, California, 94538, United States

Location

N. Florida Regional Medical Center

Gainesville, Florida, 32605, United States

Location

Munroe Regional Medical Center

Ocala, Florida, 34478, United States

Location

AnMed Health

Anderson, South Carolina, 29621, United States

Location

Related Publications (1)

• 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.

  PMID: 24754279 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Arslan Malik - Senior Clinical Research Manager
• Organization: Medtronic Aortic and Peripheral Vascular

arslan.malik@medtronic.com

(707) 541-3256

Study Officials

• John Laird, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Dierk Scheinert, PD

  Park-Krankenhaus Leipzig-Sudost GmbH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 25, 2008
• Study Start: November 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2013
• Last Updated: April 13, 2016
• Results First Posted: May 21, 2014

Record last verified: 2016-02

Locations

US (4)