Clinical Trial: Clinical Evaluation of Patients With Everolimus-eluting Stent Xience V® Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: XERES Trial: Clinical Evaluation of Patients With Everolimus-eluting Stent " Xience V® " Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis)

Brief Summary: Interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent " Xience V® " implanted in the treatment of restenosis in non-coated metallic stent (BMS in-stent restenosis) during a 2 year clinical follow-up period.

Detailed Summary:
Sponsor: Abbott Vascular

Current Primary Outcome: Evaluation by QCA (Quantitative Coronary Angiography) of in-stent late loss after the implantation of the stent XIENCE V® [ Time Frame: 9 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluation by IVUS (Intra Vascular Ultrasound) of the in-stent volume obstruction percentage (%VO) after the implantation of a XIENCE V® stent [ Time Frame: 9 months ]
  • Evaluation by IVUS of the mean volume of neointimal hyperplasia after the implantation of a XIENCE V® stent [ Time Frame: 9 months ]
  • Evaluation by QCA of the in-stent binary restenosis rate [ Time Frame: 9 months ]
  • Evaluation of the in-segment binary restenosis rate [ Time Frame: 9 months ]
  • Evaluation by QCA of in-segment late loss [ Time Frame: 9 months ]
  • Evaluation by IVUS of the in-segment % volume obstruction after the implantation of the XIENCE V® stent [ Time Frame: 9 months ]
  • Evaluation by IVUS of the rate of late incomplete apposition [ Time Frame: 9 months ]
  • Document the number of confirmed stent thrombosis [ Time Frame: 1, 8, 9, 12 and 24 months ]
  • -Document the number of confirmed revascularizations (TLR, TVR) [ Time Frame: 1, 8, 9, 12 and 24 months ]
  • Document the rate of MACE [ Time Frame: 1, 8, 9, 12 and 24 months ]


Original Secondary Outcome: Same as current

Information By: Abbott Vascular

Dates:
Date Received: April 14, 2009
Date Started: March 2009
Date Completion:
Last Updated: September 5, 2012
Last Verified: September 2012