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J Vasc Interv Radiol. 2015 Jan;26(1):21-8. doi: 10.1016/j.jvir.2014.09.018. Epub 2014 Nov 15.

S.M.A.R.T. self-expanding nitinol stent for the treatment of atherosclerotic lesions in the superficial femoral artery (STROLL): 1-year outcomes.

Author information

1
Columbia Presbyterian Medical Center/New York Presbyterian Hospital, 161 Fort Washington Avenue, New York, NY 10032. Electronic address: wg2131@cumc.columbia.edu.
2
Columbia St. Mary's Hospital, Milwaukee, Wisconsin.
3
Vascular Surgery Associates, Huntsville, Alabama.
4
Bryan LGH Heart Institute, Lincoln, Nebraska.
5
Greenville Hospital, Greenville, South Carolina.
6
First Coast Cardiovascular Institute, Jacksonville, Florida.
7
PeaceHealth St. Joseph Medical Center, Bellingham, Washington.
8
Moffitt Heart and Vascular Group, PinnacleHealth CardioVascular Institute, Wormleysburg, Pennsylvania.
9
Amarillo Heart Clinical Research Institute, Amarillo, Texas.
10
Tri-Lakes Research, Hot Springs, Arizona.
11
Cordis Clinical Research, Bridgewater, New Jersey.
12
Harvard Clinical Research Institute, Boston, Massachusetts.
13
Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston, Massachusetts.

Abstract

PURPOSE:

To assess safety and efficacy of the S.M.A.R.T. Vascular Stent System (Cordis Corp, Fremont, California) in obstructive superficial femoral artery (SFA) disease.

MATERIALS AND METHODS:

The single-arm, multicenter STROLL study (S.M.A.R.T. Nitinol Self-Expanding Stent in the Treatment of Obstructive Superficial Femoral Artery Disease) included 250 patients (250 lesions in SFA or proximal popliteal artery). The efficacy endpoint was primary patency defined by freedom from binary restenosis (peak systolic velocity ratio > 2.5) as derived by duplex ultrasound plus clinically driven target lesion revascularization (TLR) at 12 months.

RESULTS:

Mean age of patients was 67.7 years ± 10.3; 47.2% of patients had diabetes; distribution of Rutherford/Becker classes 2, 3, and 4 was 45.8%, 51.4%, and 2.8%. Mean lesion length and reference vessel diameter were 77.3 mm ± 35.3 and 4.9 mm ± 0.7, respectively (23.6% cases with total occlusions). The 30-day freedom from major adverse events (death, index limb amputation, clinically driven TLR) was 100%. The 1-year primary patency was 81.7% by Kaplan-Meier estimate. The presence of diabetes or total occlusion had no effect on primary patency. Ankle-brachial index was 0.4-0.8 in 84.6% of patients at baseline and improved to > 0.8 in 81.0% of patients at 12 months. The proportion of patients in Rutherford/Becker class 3-4 was reduced from 54.2% at baseline to 8.0% at 12 months. Four patients (2.0%) experienced single-stent strut fracture (type I) at 1 year, without associated loss of stent patency.

CONCLUSIONS:

The S.M.A.R.T. Vascular Stent System proved to be safe and effective for endovascular treatment of obstructive SFA and proximal popliteal artery disease, based on 1-year vessel patency and associated hemodynamic and clinical improvements.

PMID:
25454735
DOI:
10.1016/j.jvir.2014.09.018
[Indexed for MEDLINE]

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