Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: Twelve-month results from the complete SE multicenter trial

John R. Laird, Ash Jain, Thomas Zeller, Robert Feldman, Dierk Scheinert, Jeffrey J. Popma, Ehrin J. Armstrong, Michael R. Jaff

Research output: Contribution to journalArticle

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Abstract

Purpose: To determine the safety and efficacy of a new-generation nitinol stent with enhanced flexibility in arterial lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). Methods: The Complete Self-Expanding (SE) Multicenter Trial (ClinicalTrials.gov identifier NCT00814970) enrolled 196 patients (124 men; mean age 68.7610.5 years) from 28 centers in the United States and Europe. The patients presented with intermittent claudication (193/ 196) or ischemic rest pain (3/196) and were treated with nitinol stents for obstructive lesions of the SFA or PPA. Over a quarter of lesions (29.9%) were chronic total occlusions. The mean lesion length was 60.7 mm. Moderate to severe calcification was present in 91.0% of lesions. Results: A total of 225 stents were successfully implanted in 213 (99.5%) of 214 lesions. Acute lesion success (,30% residual stenosis) was achieved in 90.0%. There were no inhospital major adverse events. Primary patency (defined as a peak systolic velocity ratio < 2.0) at 12 months was 72.6%. Clinically-driven target lesion revascularization (TLR) was required in 8.4% of patients at 12 months. The mean ankle-brachial index increased from 0.7 at baseline to 0.9, and there was sustained improvement in the Rutherford category, with 83% of patients classified as Rutherford category 0 or 1 at 12-month follow-up. No stent fractures were detected through 12 months. Conclusion: In this multicenter trial, primary implantation of a new-generation self-expanding nitinol stent in the SFA and PPA was associated with a low rate of TLR and sustained clinical benefit at 12 months without stent fracture.

Original languageEnglish (US)
Pages (from-to)202-212
Number of pages11
JournalJournal of Endovascular Therapy
Volume21
Issue number2
DOIs
StatePublished - 2014

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Popliteal Artery
Femoral Artery
Multicenter Studies
Stents
Ankle Brachial Index
Intermittent Claudication
nitinol
Pathologic Constriction
Safety
Pain

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging
  • Medicine(all)

Cite this

Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery : Twelve-month results from the complete SE multicenter trial. / Laird, John R.; Jain, Ash; Zeller, Thomas; Feldman, Robert; Scheinert, Dierk; Popma, Jeffrey J.; Armstrong, Ehrin J.; Jaff, Michael R.

In: Journal of Endovascular Therapy, Vol. 21, No. 2, 2014, p. 202-212.

Research output: Contribution to journalArticle

Laird, John R. ; Jain, Ash ; Zeller, Thomas ; Feldman, Robert ; Scheinert, Dierk ; Popma, Jeffrey J. ; Armstrong, Ehrin J. ; Jaff, Michael R. / Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery : Twelve-month results from the complete SE multicenter trial. In: Journal of Endovascular Therapy. 2014 ; Vol. 21, No. 2. pp. 202-212.
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abstract = "Purpose: To determine the safety and efficacy of a new-generation nitinol stent with enhanced flexibility in arterial lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). Methods: The Complete Self-Expanding (SE) Multicenter Trial (ClinicalTrials.gov identifier NCT00814970) enrolled 196 patients (124 men; mean age 68.7610.5 years) from 28 centers in the United States and Europe. The patients presented with intermittent claudication (193/ 196) or ischemic rest pain (3/196) and were treated with nitinol stents for obstructive lesions of the SFA or PPA. Over a quarter of lesions (29.9{\%}) were chronic total occlusions. The mean lesion length was 60.7 mm. Moderate to severe calcification was present in 91.0{\%} of lesions. Results: A total of 225 stents were successfully implanted in 213 (99.5{\%}) of 214 lesions. Acute lesion success (,30{\%} residual stenosis) was achieved in 90.0{\%}. There were no inhospital major adverse events. Primary patency (defined as a peak systolic velocity ratio < 2.0) at 12 months was 72.6{\%}. Clinically-driven target lesion revascularization (TLR) was required in 8.4{\%} of patients at 12 months. The mean ankle-brachial index increased from 0.7 at baseline to 0.9, and there was sustained improvement in the Rutherford category, with 83{\%} of patients classified as Rutherford category 0 or 1 at 12-month follow-up. No stent fractures were detected through 12 months. Conclusion: In this multicenter trial, primary implantation of a new-generation self-expanding nitinol stent in the SFA and PPA was associated with a low rate of TLR and sustained clinical benefit at 12 months without stent fracture.",
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AU - Laird, John R.

AU - Jain, Ash

AU - Zeller, Thomas

AU - Feldman, Robert

AU - Scheinert, Dierk

AU - Popma, Jeffrey J.

AU - Armstrong, Ehrin J.

AU - Jaff, Michael R.

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N2 - Purpose: To determine the safety and efficacy of a new-generation nitinol stent with enhanced flexibility in arterial lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). Methods: The Complete Self-Expanding (SE) Multicenter Trial (ClinicalTrials.gov identifier NCT00814970) enrolled 196 patients (124 men; mean age 68.7610.5 years) from 28 centers in the United States and Europe. The patients presented with intermittent claudication (193/ 196) or ischemic rest pain (3/196) and were treated with nitinol stents for obstructive lesions of the SFA or PPA. Over a quarter of lesions (29.9%) were chronic total occlusions. The mean lesion length was 60.7 mm. Moderate to severe calcification was present in 91.0% of lesions. Results: A total of 225 stents were successfully implanted in 213 (99.5%) of 214 lesions. Acute lesion success (,30% residual stenosis) was achieved in 90.0%. There were no inhospital major adverse events. Primary patency (defined as a peak systolic velocity ratio < 2.0) at 12 months was 72.6%. Clinically-driven target lesion revascularization (TLR) was required in 8.4% of patients at 12 months. The mean ankle-brachial index increased from 0.7 at baseline to 0.9, and there was sustained improvement in the Rutherford category, with 83% of patients classified as Rutherford category 0 or 1 at 12-month follow-up. No stent fractures were detected through 12 months. Conclusion: In this multicenter trial, primary implantation of a new-generation self-expanding nitinol stent in the SFA and PPA was associated with a low rate of TLR and sustained clinical benefit at 12 months without stent fracture.

AB - Purpose: To determine the safety and efficacy of a new-generation nitinol stent with enhanced flexibility in arterial lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). Methods: The Complete Self-Expanding (SE) Multicenter Trial (ClinicalTrials.gov identifier NCT00814970) enrolled 196 patients (124 men; mean age 68.7610.5 years) from 28 centers in the United States and Europe. The patients presented with intermittent claudication (193/ 196) or ischemic rest pain (3/196) and were treated with nitinol stents for obstructive lesions of the SFA or PPA. Over a quarter of lesions (29.9%) were chronic total occlusions. The mean lesion length was 60.7 mm. Moderate to severe calcification was present in 91.0% of lesions. Results: A total of 225 stents were successfully implanted in 213 (99.5%) of 214 lesions. Acute lesion success (,30% residual stenosis) was achieved in 90.0%. There were no inhospital major adverse events. Primary patency (defined as a peak systolic velocity ratio < 2.0) at 12 months was 72.6%. Clinically-driven target lesion revascularization (TLR) was required in 8.4% of patients at 12 months. The mean ankle-brachial index increased from 0.7 at baseline to 0.9, and there was sustained improvement in the Rutherford category, with 83% of patients classified as Rutherford category 0 or 1 at 12-month follow-up. No stent fractures were detected through 12 months. Conclusion: In this multicenter trial, primary implantation of a new-generation self-expanding nitinol stent in the SFA and PPA was associated with a low rate of TLR and sustained clinical benefit at 12 months without stent fracture.

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