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Title: Endovascular Treatment of Peripheral Artery Disease with Expanded PTFE-Covered Nitinol Stents: Interim Analysis from a Prospective Controlled Study

Abstract

Purpose: Current covered peripheral stent designs have significant drawbacks in terms of stent delivery characteristics and flexibility. The aim of this study was to analyze the technical performance, safety and initial clinical efficacy of expanded polytetrafluoroethylene (PTFE)-covered nitinol stents for arteriosclerotic peripheral artery disease. Methods:Eighty-two patients underwent implantation of PTFE-covered nitinol stents for iliac and/or femoral obstructions. The study was conducted prospectively in seven European centers and one Canadian center. Patients were controlled clinically and by duplex ultrasound follow-up. Data up to discharge were collected in 79 patients. Seventy-four patients have thus far received 1 month follow-up and 32 patients, 6 month follow-up examinations. Results: The average lesion length measured 47 mm for the common and external iliac arteries and 50 mm for the femoral arteries. The mean severity of the stenoses was reduced from 94% to 4% in the iliac arteries and from 98% to 7% in the femoral arteries after stent placement and dilatation. One device deviation (inadvertent stent misplacement) and one puncture-related severe adverse event with formation of a pseudoaneurysm occurred. There were occlusions of the stent in five patients. No infections were noticed. Conclusion: The interim analysis of this trial using PTFE-covered nitinol stents indicates thatmore » a strategy using primary implantation of this stent type is technically feasible, has an acceptable safety profile and is effective from a short-term perspective.« less

Authors:
 [1];  [2];  [1];  [3];  [4];  [5];  [6]; ;  [1];  [7];  [8]
  1. Division of Diagnostic Radiology, Department of Radiology, University of Tuebingen, Tuebingen (Germany)
  2. Dienst Vaatchirurgie, Sint Blasius Ziekenhuis, Dendermonde (Belgium)
  3. Institute for Cardiac and Vascular Surgery, Semmelweis University, Budapest (Hungary)
  4. Department of Radiology, CHUM, Montreal (Canada)
  5. Department of Radiology, University of Kiel, Kiel (Germany)
  6. Vascular and Endovascular Surgery, Lake Macquaire Hospital, Newcastle (Australia)
  7. Cordis Clinical Research Europe, Waterloo (Belgium)
  8. CHRU, Hopital Cardiologique, Lille (France)
Publication Date:
OSTI Identifier:
21083413
Resource Type:
Journal Article
Journal Name:
Cardiovascular and Interventional Radiology
Additional Journal Information:
Journal Volume: 25; Journal Issue: 5; Other Information: DOI: 10.1007/s00270-002-1849-5; Copyright (c) 2002 Springer-Verlag New York, Inc; Country of input: International Atomic Energy Agency (IAEA); Journal ID: ISSN 0174-1551
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; ARTERIES; FLEXIBILITY; NICKEL ALLOYS; PATIENTS; POLYTETRAFLUOROETHYLENE; TITANIUM ALLOYS; VASCULAR DISEASES

Citation Formats

Duda, S H, Bosiers, M, Pusich, B, Huettl, K, Oliva, V, Mueller-Huelsbeck, S, Bray, A, Luz, O, Remy, C, Hak, J B, and Beregi, J -P. Endovascular Treatment of Peripheral Artery Disease with Expanded PTFE-Covered Nitinol Stents: Interim Analysis from a Prospective Controlled Study. United States: N. p., 2002. Web. doi:10.1007/S00270-002-1849-5.
Duda, S H, Bosiers, M, Pusich, B, Huettl, K, Oliva, V, Mueller-Huelsbeck, S, Bray, A, Luz, O, Remy, C, Hak, J B, & Beregi, J -P. Endovascular Treatment of Peripheral Artery Disease with Expanded PTFE-Covered Nitinol Stents: Interim Analysis from a Prospective Controlled Study. United States. https://doi.org/10.1007/S00270-002-1849-5
Duda, S H, Bosiers, M, Pusich, B, Huettl, K, Oliva, V, Mueller-Huelsbeck, S, Bray, A, Luz, O, Remy, C, Hak, J B, and Beregi, J -P. 2002. "Endovascular Treatment of Peripheral Artery Disease with Expanded PTFE-Covered Nitinol Stents: Interim Analysis from a Prospective Controlled Study". United States. https://doi.org/10.1007/S00270-002-1849-5.
@article{osti_21083413,
title = {Endovascular Treatment of Peripheral Artery Disease with Expanded PTFE-Covered Nitinol Stents: Interim Analysis from a Prospective Controlled Study},
author = {Duda, S H and Bosiers, M and Pusich, B and Huettl, K and Oliva, V and Mueller-Huelsbeck, S and Bray, A and Luz, O and Remy, C and Hak, J B and Beregi, J -P},
abstractNote = {Purpose: Current covered peripheral stent designs have significant drawbacks in terms of stent delivery characteristics and flexibility. The aim of this study was to analyze the technical performance, safety and initial clinical efficacy of expanded polytetrafluoroethylene (PTFE)-covered nitinol stents for arteriosclerotic peripheral artery disease. Methods:Eighty-two patients underwent implantation of PTFE-covered nitinol stents for iliac and/or femoral obstructions. The study was conducted prospectively in seven European centers and one Canadian center. Patients were controlled clinically and by duplex ultrasound follow-up. Data up to discharge were collected in 79 patients. Seventy-four patients have thus far received 1 month follow-up and 32 patients, 6 month follow-up examinations. Results: The average lesion length measured 47 mm for the common and external iliac arteries and 50 mm for the femoral arteries. The mean severity of the stenoses was reduced from 94% to 4% in the iliac arteries and from 98% to 7% in the femoral arteries after stent placement and dilatation. One device deviation (inadvertent stent misplacement) and one puncture-related severe adverse event with formation of a pseudoaneurysm occurred. There were occlusions of the stent in five patients. No infections were noticed. Conclusion: The interim analysis of this trial using PTFE-covered nitinol stents indicates that a strategy using primary implantation of this stent type is technically feasible, has an acceptable safety profile and is effective from a short-term perspective.},
doi = {10.1007/S00270-002-1849-5},
url = {https://www.osti.gov/biblio/21083413}, journal = {Cardiovascular and Interventional Radiology},
issn = {0174-1551},
number = 5,
volume = 25,
place = {United States},
year = {Tue Oct 15 00:00:00 EDT 2002},
month = {Tue Oct 15 00:00:00 EDT 2002}
}