Promising, but still a matter of debate

Yohei Sotomi; Patrick W. Serruys

doi:10.1002/ccd.26729

Promising, but still a matter of debate

Yohei Sotomi
, Patrick W. Serruys

Research output: Contribution to journal › Editorial › Academic › peer-review

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Abstract

Several trials failed to demonstrate the efficacy of plaque modification device in patients with severely calcified coronary lesions. Safety and efficacy of the Diamondback 360® Coronary OAS have been demonstrated by the ORBIT II trial. The 2-year follow-up of the ORBIT II trial extends the favorable results previously shown at 30-day and 1-year follow-up. The single arm, non-randomized character of the trial with indirect historical comparison may restrict the results to hypothesis generating and entail further prospective randomized trials

Original language	English
Pages (from-to)	378-379
Journal	Catheterization and cardiovascular interventions
Volume	88
Issue number	3
DOIs	https://doi.org/10.1002/ccd.26729
Publication status	Published - 2016

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Promising-but-still-a-matter-of-debate.pdfFinal published version, 32.1 KBLicence: Taverne

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title = "Promising, but still a matter of debate",

abstract = "Several trials failed to demonstrate the efficacy of plaque modification device in patients with severely calcified coronary lesions. Safety and efficacy of the Diamondback 360{\textregistered} Coronary OAS have been demonstrated by the ORBIT II trial. The 2-year follow-up of the ORBIT II trial extends the favorable results previously shown at 30-day and 1-year follow-up. The single arm, non-randomized character of the trial with indirect historical comparison may restrict the results to hypothesis generating and entail further prospective randomized trials",

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AU - Sotomi, Yohei

AU - Serruys, Patrick W.

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AB - Several trials failed to demonstrate the efficacy of plaque modification device in patients with severely calcified coronary lesions. Safety and efficacy of the Diamondback 360® Coronary OAS have been demonstrated by the ORBIT II trial. The 2-year follow-up of the ORBIT II trial extends the favorable results previously shown at 30-day and 1-year follow-up. The single arm, non-randomized character of the trial with indirect historical comparison may restrict the results to hypothesis generating and entail further prospective randomized trials

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JO - Catheterization and cardiovascular interventions

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Promising, but still a matter of debate

Abstract

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