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Clinical results for the training‐phase roll‐in patients in the intracoil femoralpopliteal stent trial
Author(s) -
Ansel Gary M.,
Botti Charles F.,
George Barry S.,
Kazienko Brian T.
Publication year - 2002
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.10252
Subject(s) - medicine , mace , stent , surgery , ankle , lesion , clinical trial , popliteal artery , target lesion , adverse effect , radiology , myocardial infarction , percutaneous coronary intervention
Abstract The purpose of this study was to report the results of the roll‐in patients for the multicenter IntraCoil trial in the femoropopliteal arteries at 9‐month follow‐up. Ninety‐three roll‐in patients (mean age, 67.8 ± 10.5 years; 62.4% male gender) constituted the learning phase for the 22 clinical sites. Obstructive femoropopliteal artery disease up to 15 cm was treated with stenting. Clinical patency was measured over a 9‐month period by clinical and hemodynamic data as well as the Rutherford scale. Diabetes mellitus was present in 35.5%. Twenty‐nine percent of lesions treated were occlusions. The mean reference diameter for treated lesions was 4.27 ± 1.11 mm, while the mean lesion length was 3.83 ± 3.69 cm. Acute angiographic success by operator evaluation was obtained in 98.9% of patients. Major complications occurred in 3.2%. No patient experienced abrupt or subacute closure. There were two reports of failure to deliver assigned stent. In both incidences, the stent was removed without surgical intervention. There were also three reports of stent misplacement (moving during delivery), one report of stent migration, one report of delivery system failure. At 30‐day and 9‐month follow‐up of successfully treated patients, 100%/77.9% remained free of major adverse clinical events (MACE) and 100%/81.8% target lesion revascularization (TLR), respectively. At 9‐month follow‐up, ankle‐brachial index increased from 0.66 ± 0.22 to 0.83 ± 0.20 while mean maximum walking time increased form 4.47 ± 3.02 to 5.91 ± 3.97 min. The use of the IntraCoil stent appears to have a short learning curve. Excellent clinical and hemodynamic patency is seen at 9 months. The randomized comparison trial comparing the IntraCoil to angioplasty is pending. Cathet Cardiovasc Intervent 2002;56:443–449. © 2002 Wiley‐Liss, Inc.