Coronary Restenosis
Conditions
Keywords
drug-eluting stent, drug-coated Balloon, recurrent In-Stent restenosis
Brief summary
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.
Interventions
DEVICEEverolimus-eluting balloon expandable stent
Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)
paclitaxel eluting balloon (SeQuent Please)
Sponsors
CardioVascular Research Foundation, Korea
Seung-Jung Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late luminal loss | 9months | Late luminal loss at 9 months angiographic follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarction | 1 year | — |
| Target lesion revascularization | 1 year | — |
| Target vessel revascularization | 1 year | — |
| Death | 1 year | — |
| In-segment or in-stent restenosis at 9 month angiographic follow-up | 1 year | — |
| Procedural success | 3day | 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. |
| Stent thrombosis | 1 year | — |
Countries
South Korea
Outcome results
None listed