2005
DOI: 10.1111/j.1540-8183.2005.00039.x
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A Randomized, Controlled Trial of Saphenous Vein Graft Intervention with a Filter‐Based Distal Embolic Protection Device: TRAP Trial

Abstract: The purpose of this prospective, multicenter trial was to evaluate the safety and effectiveness of the TRAP Vascular Filtration System (VFS) to reduce embolic complications during stenting of diseased saphenous vein grafts (SVGs). Patients with SVG lesions were randomly assigned to undergo stenting with or without the TRAP device. The trial was designed to enroll 752 randomized patients. However, the sponsor terminated the study after a total of 467 patients (358 randomized) were enrolled because of poor recru… Show more

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Cited by 27 publications
(12 citation statements)
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References 21 publications
(44 reference statements)
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“…64 Subsequent filter and proximal occluder EPDs have been compared with these devices in various other clinical trials, also with noninferiority designs. [65][66][67][68] All these studies yielded positive results, but the differences in study design (superiority versus noninferiorty) justify the class Ib recommendation for the use of EPDs in clinical guidelines. 1 Embolic risk in SVGs is particularly high in patients with a large volume of occluding atheroma.…”
Section: Secondary Pci In Svgsmentioning
confidence: 85%
“…64 Subsequent filter and proximal occluder EPDs have been compared with these devices in various other clinical trials, also with noninferiority designs. [65][66][67][68] All these studies yielded positive results, but the differences in study design (superiority versus noninferiorty) justify the class Ib recommendation for the use of EPDs in clinical guidelines. 1 Embolic risk in SVGs is particularly high in patients with a large volume of occluding atheroma.…”
Section: Secondary Pci In Svgsmentioning
confidence: 85%
“…. 17 However, the TRAP trial was terminated early because of slow enrollment. Subsequent trials of EPDs (including those for the FilterWire 18 and SpideRx 19 ) have relied on the contemporary relevance of the SAFER control cohort with noninferiority trial designs.…”
Section: Discussionmentioning
confidence: 99%
“…The significantly higher incidence of peri-procedural MI in EPDs SVG PCI was also noted in comprehensive review and meta-analysis prepared by Paul et al [10]. The Randomized, Controlled Trial of SVG PCI with the TRAP-EPD (Microvena, White Bear Lake, MN) demonstrated no differences in deaths, MI, TVR, MACE in the TRAP-EPDs group compared with no-EPDs group at 30-days follow up [17]. These abovementioned outcomes challenged the role of adjunct EPDs in SVG PCI, questioning both its safety and efficacy.…”
Section: Discussionmentioning
confidence: 68%