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

Coronary Restenosis Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01967199
• Other study ID #: AMCCV2013-01
• Status: Terminated
• Phase: Phase 4
• First received: October 17, 2013
• Last updated: February 23, 2017
• Start date: April 18, 2013
• Est. completion date: February 14, 2017

Study information

• Verified date: February 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 175
• Est. completion date: February 14, 2017
• Est. primary completion date: February 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Restenosis

Intervention

Device:
• Everolimus-eluting balloon expandable stent
Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)
• paclitaxel eluting balloon
paclitaxel eluting balloon (SeQuent Please)

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon
Korea, Republic of	Chungbuk National University Hospital	Chungjoo
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	National Health Insurance Service Ilsan Hospital	Ilsan
Korea, Republic of	Dong-A Medical Center	Pusan
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late luminal loss	Late luminal loss at 9 months angiographic follow-up.	9months
Secondary	Death		1 year
Secondary	Myocardial infarction		1 year
Secondary	Target lesion revascularization		1 year
Secondary	Target vessel revascularization		1 year
Secondary	Stent thrombosis		1 year
Secondary	In-segment or in-stent restenosis at 9 month angiographic follow-up		1 year
Secondary	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