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

Study Overview
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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.

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

Conditions
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Coronary Restenosis

Intervention / Treatment
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* Device: Everolimus-eluting balloon expandable stent
* Device: paclitaxel eluting balloon


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug Eluting Stent<br>Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) | Device: Everolimus-eluting balloon expandable stent<br>* Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)<br>|
| Experimental: paclitaxel eluting balloon<br>paclitaxel eluting balloon (SeQuent Please) | Device: paclitaxel eluting balloon<br>* paclitaxel eluting balloon (SeQuent Please)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late luminal loss | Late luminal loss at 9 months angiographic follow-up. | 9months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 1 year | 
| Myocardial infarction |  | 1 year | 
| Target lesion revascularization |  | 1 year | 
| Target vessel revascularization |  | 1 year | 
| Stent thrombosis |  | 1 year | 
| In-segment or in-stent restenosis at 9 month angiographic follow-up |  | 1 year | 
| Procedural success | defined as achievement of a final diameter stenosis of <30% by QCA(Quantitative Coronary Angiography) using any percutaneous method, without the occurrence of death, Q wave Myocardial Infarction, or repeat revascularization of the target lesion during the hospital stay. participants will be followed for the duration of hospital stay, an expected average of 3days. | 3day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug-eluting stent, drug-coated Balloon, recurrent In-Stent restenosis