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

Phase 4

Terminated

• Conditions: Coronary Restenosis
• Interventions: Device: paclitaxel eluting balloon; Device: Everolimus-eluting balloon expandable stent

• Registration Number: NCT01967199
• Lead Sponsor: Seung-Jung Park

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-18
• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-22
• Status Verified: 2017-02
• Primary Completion: 2017-02-14
• Study Completion: 2017-02-14
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
paclitaxel eluting balloon	paclitaxel eluting balloon	paclitaxel eluting balloon (SeQuent Please)
Drug Eluting Stent	Everolimus-eluting balloon expandable stent	Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)

Primary Outcome Measures

Name	Time	Method
Late luminal loss	9months	Late luminal loss at 9 months angiographic follow-up.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (11)

Soon Chun Hyang University Hospital Bucheon; 🇰🇷 Bucheon, Korea, Republic of

Chungbuk National University Hospital; 🇰🇷 Chungjoo, Korea, Republic of

Dong-A Medical Center; 🇰🇷 Pusan, Korea, Republic of

The Catholic University of Korea, Daejeon ST. Mary's Hospital; 🇰🇷 Daejeon, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

National Health Insurance Service Ilsan Hospital; 🇰🇷 Ilsan, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of