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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-18

Study Completion Date

2017-02-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Restenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug Eluting Stent

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

Group Type ACTIVE_COMPARATOR

Everolimus-eluting balloon expandable stent

Intervention Type DEVICE

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

paclitaxel eluting balloon

paclitaxel eluting balloon (SeQuent Please)

Group Type EXPERIMENTAL

paclitaxel eluting balloon

Intervention Type DEVICE

paclitaxel eluting balloon (SeQuent Please)

Interventions

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Everolimus-eluting balloon expandable stent

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

Intervention Type DEVICE

paclitaxel eluting balloon

paclitaxel eluting balloon (SeQuent Please)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No