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

• Sponsor: Seung-Jung Park (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01967199
• Collaborator: CardioVascular Research Foundation, Korea (Other)
• Enrollment: 175
• Locations: 11
• Arms: 2
• Actual Duration (Months): 45.9
• Patients Per Site: 15.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Restenosis	Device: Everolimus-eluting balloon expandable stent; Device: paclitaxel eluting balloon	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 175 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Drug-Eluting Stent REstenosis Using Drug-Eluting STents vs. Drug-COated Balloon for Preventing REcurrent In-Stent Restenosis
• Actual Study Start Date: Apr 18, 2013
• Actual Primary Completion Date: Feb 14, 2017
• Actual Study Completion Date: Feb 14, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Drug Eluting Stent Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)	Device: Everolimus-eluting balloon expandable stent; Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)
Experimental: paclitaxel eluting balloon paclitaxel eluting balloon (SeQuent Please)	Device: paclitaxel eluting balloon; paclitaxel eluting balloon (SeQuent Please)

Outcome Measures

Primary Outcome Measures

1. Late luminal loss [9months]

   Late luminal loss at 9 months angiographic follow-up.

Secondary Outcome Measures

1. Death [1 year]

2. Myocardial infarction [1 year]

3. Target lesion revascularization [1 year]

4. Target vessel revascularization [1 year]

5. Stent thrombosis [1 year]

6. In-segment or in-stent restenosis at 9 month angiographic follow-up [1 year]

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul	Songpa-gu	Korea, Republic of	138-736
2	Soon Chun Hyang University Hospital Bucheon	Bucheon		Korea, Republic of
3	Chungbuk National University Hospital	Chungjoo		Korea, Republic of
4	Daegu Catholic University Medical Center	Daegu		Korea, Republic of
5	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
6	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon		Korea, Republic of
7	Chonnam National University Hospital	Gwangju		Korea, Republic of
8	National Health Insurance Service Ilsan Hospital	Ilsan		Korea, Republic of
9	Dong-A Medical Center	Pusan		Korea, Republic of
10	Seoul National University Boramae Medical Center	Seoul		Korea, Republic of
11	Ulsan University Hospital	Ulsan		Korea, Republic of

Sponsors and Collaborators

• Seung-Jung Park
• CardioVascular Research Foundation, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seung-Jung Park, M.D, Ph.D., Asan Medical Center
• ClinicalTrials.gov Identifier: NCT01967199
• Other Study ID Numbers: AMCCV2013-01
• First Posted: Oct 22, 2013
• Last Update Posted: Feb 24, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Seung-Jung Park, M.D, Ph.D., Asan Medical Center: drug-eluting stent; drug-coated Balloon; recurrent In-Stent restenosis
• Additional relevant MeSH terms: Coronary Restenosis; Paclitaxel; Everolimus

Study Results

No Results Posted as of Feb 24, 2017