title: Early experimental and clinical experience with a focal implant for lower extremity post-angioplasty dissection.
abstract: OBJECTIVE
  This study provides preliminary data on the safety and feasibility of the use of a novel focal implant for managing post-percutaneous transluminal balloon angioplasty (post-PTA) dissection.
  
  
  BACKGROUND
  Post-PTA dissection of the lower extremity arteries is managed with stent placement. This provides an acceptable post-intervention result but has long-term disadvantages, such as in-stent restenosis. Focal treatment of post-PTA dissection and avoidance of stents are the objectives of the Tack-It (Intact Vascular, Inc., Wayne, Pennsylvania) device.
  
  
  METHODS
  A preclinical study and first-in-human data are presented. Seven swine underwent superficial femoral artery device placement, with a self-expanding nitinol stent on 1 side and a series of 4 Tack-It devices on the other side. Specimens were harvested at 28 days. The clinical study included 15 limbs that underwent revascularization for critical limb ischemia (n = 9) or claudication (n = 6). Twenty-five lesions were treated in the superficial femoral (n = 8), popliteal (n = 7), and tibial (n = 10) arteries.
  
  
  RESULTS
  The preclinical study demonstrated a reduction in stenosis with the Tack-It (16.8 ± 2.6%) compared with stents (46.4 ± 9.8%). Neointimal thickness and injury score decreased with the Tack-It. Clinically, Tack-It placement resulted in acute technical success with resolution of the post-PTA dissection in 100% of lesions. There were no device-related complications or major amputations. Eighteen of the 25 lesions were available for angiographic follow-up at 1-year, and patency was 83.3%.
  
  
  CONCLUSIONS
  Preclinical data suggest that the Tack-It device causes minimal vessel injury. Clinical use of the Tack-It to manage post-PTA dissection was safe and feasible in this early study and resulted in apposition of dissection flaps without stent placement.
authors.affiliation: Kaiser Foundation Hospital, Honolulu, Hawaii. Electronic address: peterschneidermd@aol.com.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Schneider
authors.affiliation: Intact Vascular, Inc., Wayne, Pennsylvania.
authors.forename: Robert
authors.initials: R
authors.lastname: Giasolli
authors.affiliation: The Italian Hospital, Asuncion, Paraguay.
authors.forename: Adrian
authors.initials: A
authors.lastname: Ebner
authors.affiliation: CV Path, Gaithersburg, Maryland.
authors.forename: Renu
authors.initials: R
authors.lastname: Virmani
authors.affiliation: Skirball Research Center, Cardiovascular Research Foundation, Orangeburg, New York.
authors.forename: Juan F
authors.initials: JF
authors.lastname: Granada
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D000800:Angioplasty, Balloon / Q000009:adverse effects* / Q000295:instrumentation; D000818:Animals; D001157:Arterial Occlusive Diseases / Q000628:therapy*; D004195:Disease Models, Animal; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D035002:Lower Extremity / Q000098:blood supply* / Q000293:injuries*; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D016491:Peripheral Vascular Diseases / Q000628:therapy*; D011446:Prospective Studies; D015607:Stents; D013552:Swine
keywords: angioplasty; dissection; tack