Drug-eluting Stents vs. Drug-coated Balloon for Preventing Recurrent In-stent Restenosis

Treatment of Drug-Eluting Stent REstenosis Using Drug-Eluting STents vs. Drug-COated Balloon for Preventing REcurrent In-Stent Restenosis

The purpose of this study is to establish the safety and effectiveness of paclitaxel eluting balloon (SeQuent Please) compared to coronary stenting with the Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) in the treatment of drug eluting stent restenosis.

Inclusion Criteria:

• The patient must be more than or equal to 20 years of age
• Restenosis after drug-eluting stents (>50% by visual estimate)
• Any Lesion length including focal in stent restenosis or diffuse in stent restenosis
• The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

• The patient has a known hypersensitivity or contraindication to any of the following medications:

  • Heparin
  • Aspirin
  • Both Clopidogrel and TIclopidine
  • Sirolimus eluting stent
  • Stainless steel and/or
  • Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled)

• Systemic (intravenous) Everolimus use within 12 months.

• Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study

• Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)

• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period