Clinical trial NCT01092416 - References

Coronary Artery Disease — Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions

Citation(s)

•   Chambers JW, Feldman RL, Himmelstein SI, Bhatheja R, Villa AE, Strickman NE, Shlofmitz RA, Dulas DD, Arab D, Khanna PK, Lee AC, Ghali MG, Shah RR, Davis TP, Kim CY, Tai Z, Patel KC, Puma JA, Makam P, Bertolet BD, Nseir GY
  Pivotal trial to evaluate the sa
•   Genereux P, Bettinger N, Redfors B, Lee AC, Kim CY, Lee MS, Shlofmitz RA, Moses JW, Stone GW, Chambers JW
  Two-year outcomes after treatment of severely calcified coronary lesions with the orbital atherectomy system and the impact of stent types: Insight
•   Genereux P, Lee AC, Kim CY, Lee M, Shlofmitz R, Moses JW, Stone GW, Chambers JW
  Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial). Am J Cardiol. 2015 Jun 15;115(12):1685-90. do
•   Kim CY, Lee AC, Wiedenbeck TL, Lee MS, Chambers JW
  Gender differences in acute and 30-day outcomes after orbital atherectomy treatment of de novo, severely calcified coronary lesions. Catheter Cardiovasc Interv. 2016 Mar;87(4):671-7. doi: 10.1002/ccd.261
•   Lee M, Genereux P, Shlofmitz R, Phillipson D, Anose BM, Martinsen BJ, Himmelstein SI, Chambers JW
  Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial. Cardiovasc Revasc Med. 2017 Jun
•   Lee MS, Anose BM, Martinsen BJ, Lee AC, Shlofmitz RA, Chambers JW
  Orbital atherectomy treatment of severely calcified native coronary lesions in patients with prior coronary artery bypass grafting: Acute and one-year outcomes from the ORBIT II trial. Car
•   Lee MS, Lee AC, Shlofmitz RA, Martinsen BJ, Hargus NJ, Elder MD, Genereux P, Chambers JW
  ORBIT II sub-analysis: Impact of impaired renal function following treatment of severely calcified coronary lesions with the Orbital Atherectomy System. Catheter Car
•   Lee MS, Martinsen BJ, Lee AC, Behrens AN, Shlofmitz RA, Kim CY, Chambers JW
  Impact of diabetes mellitus on procedural and one year clinical outcomes following treatment of severely calcified coronary lesions with the orbital atherectomy system: A subanal
•   Lee MS, Martinsen BJ, Shlofmitz R, Shlofmitz E, Lee AC, Chambers J
  Orbital atherectomy treatment of severely calcified coronary lesions in patients with impaired left ventricular ejection fraction: one-year outcomes from the ORBIT II study. EuroIntervent
•   Lee MS, Shlofmitz E, Shlofmitz R, Sahni S, Martinsen B, Chambers J
  Outcomes After Orbital Atherectomy of Severely Calcified Left Main Lesions: Analysis of the ORBIT II Study. J Invasive Cardiol. 2016 Sep;28(9):364-9. Epub 2016 Mar 15.
•   Lee MS, Shlofmitz RA, Martinsen BJ, Sethi S, Chambers JW
  Impact of age following treatment of severely calcified coronary lesions with the orbital atherectomy system: 3-year follow-up. Cardiovasc Revasc Med. 2018 Sep;19(6):655-659. doi: 10.1016/j.carrev.
•   Lee MS, Shlofmitz RA, Shlofmitz E, Behrens AN, Revtyak G, Martinsen BJ, Chambers JW
  Procedural and Long-Term Ischemic Outcomes of Tight Subtotal Occlusions Treated with Orbital Atherectomy: An ORBIT II Subanalysis. Cardiovasc Revasc Med. 2019 Jul;20(7):5
•   Lee MS, Shlofmitz RA, Shlofmitz E, Srivastava PK, Kong J, Grines C, Revytak G, Chambers JW
  Orbital atherectomy for the treatment of small (2.5mm) severely calcified coronary lesions: ORBIT II sub-analysis. Cardiovasc Revasc Med. 2018 Apr;19(3 Pt A):268-2
•   Shlofmitz E, Martinsen B, Lee M, Genereux P, Behrens A, Kumar G, Puma J, Shlofmitz R, Chambers J
  Utilizing intravascular ultrasound imaging prior to treatment of severely calcified coronary lesions with orbital atherectomy: An ORBIT II sub-analysis. J In
•   Shlofmitz E, Martinsen BJ, Behrens AN, Ali ZA, Lee MS, Puma JA, Shlofmitz RA, Chambers JW
  Direct Stenting in Patients Treated with Orbital Atherectomy: An ORBIT II Subanalysis. Cardiovasc Revasc Med. 2019 Jun;20(6):454-460. doi: 10.1016/j.carrev.2019.03.

Pivotal Trial to Evaluate the Safety and Efficacy of the Diamondback 360°® Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II)

Details for clinical trial NCT01092416