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

Seung-Jung Park

Status and phase: Terminated; Phase 4

Conditions: Coronary Restenosis

Treatments: Device: paclitaxel eluting balloon; Device: Everolimus-eluting balloon expandable stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01967199

AMCCV2013-01

Details and patient eligibility

About

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.

Enrollment: 175 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 2 patient groups

Drug Eluting Stent

Active Comparator group

Description:

Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)

Treatment:

Device: Everolimus-eluting balloon expandable stent

paclitaxel eluting balloon

Experimental group

Description:

paclitaxel eluting balloon (SeQuent Please)

Treatment:

Device: paclitaxel eluting balloon