N/A N=196 Treatment

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

Peripheral Vascular Disease

Bottom Line

View on ClinicalTrials.gov: NCT00814970 ↗

Enrolled (actual)

196

Serious AEs

59.7%

Results posted

May 2014

Primary outcome: Primary: Major Adverse Event (MAE) Rate — 11.0 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Complete SE Vascular Stent System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medtronic Endovascular
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Major Adverse Event (MAE) Rate	30.2	—
PRIMARY Primary Patency Rate	72.6	—
SECONDARY Major Adverse Event (MAE) Rate	30.2	—
SECONDARY Major Adverse Event (MAE) Rate	30.2	—
SECONDARY Device Success	90.0	—
SECONDARY Lesion Success	90.0	—
SECONDARY Procedure Success	89.1	—
SECONDARY Assisted Primary Patency	78.3	—
SECONDARY Secondary Patency Rate	78.9	—
SECONDARY Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category	90.9	—
SECONDARY Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15	64.5	—
SECONDARY Change in Quality of Life - Decrease in Rutherford Class >= 1 Category	89.7	—
SECONDARY Percentage of Participants Free From Strut Fractures	100.0	—
SECONDARY Clinically-driven Target Lesion Revascularization (TLR) Rate	8.4	—
SECONDARY Major Adverse Event (MAE) Rate	30.2	—
SECONDARY Percentage of Participants Free From Strut Fractures	100.0	—
SECONDARY Major Adverse Event (MAE) Rate	30.2	—
SECONDARY Percentage of Participants Free From Strut Fractures	100.0	—

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).

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) 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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00814970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.