New Generation Drug Eluting Stent for In-stent Restenosis of Drug Eluting Stent( RESTENT-ISR Trial )

In-stent Arterial Restenosis Clinical Trial

— Restenosis  

Official title:

Prospective, Single-blinded, Randomized Comparison of the Clinical and Angiographic Results With Intravascular Analysis of EverolimuS-Eluting Versus ZoTarolimus-Eluting steNTs for In-Stent Restenosis(ISR) Lesions: Volumetric Analysis With Intravascular Ultrasound(IVUS) : Phase IV Multicenter Trial ( RESTENT-ISR Trial )

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01365572
• Other study ID #: AN09049-004
• Status: Recruiting
• Phase: Phase 4
• First received: May 31, 2011
• Last updated: June 2, 2011
• Start date: January 2010
• Est. completion date: March 2012

Study information

• Verified date: March 2011
• Source: Korea University Anam Hospital
• Contact: Korea University Anam Hospital Ahn, MD, PhD
• Phone: +82-2-920-5445
• Email: drcello[@]kumc.or.kr
• Is FDA regulated: No
• Health authority: Republic of Korea : Korea Food and Drug Adminstration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility, safety, and effectiveness of EndeavorTM ResoluteTM and Xience VTM stent implantation in patients with restenosis following drug-eluting stent (DES) implantation. The investigators will evaluate clinical, angiographic and intravascular ultrasound (IVUS) assessment of 9-month efficacy of EndeavorTM ResoluteTM or Xience VTM implantation in DES restenosis and assess the vascular changes of re-treatment with DES for DES restenosis using follow-up IVUS analysis. In addition, the investigators will evaluate the effectiveness of retreatment with EndeavorTM ResoluteTM or Xience VTM stent implantation in patients with restenosis after DES

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 292
• Est. completion date: March 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• In-stent restenosis (over 50% by quantitative angiographic analysis) following all types of DES; only insegment restenotic lesions without ISR are not included

• Evidence of myocardial ischemia due to restenosis (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the ECG with or without ischemia) or over 70% by quantitative angiographic analysis

• Repeat revascularization, needed with another stent (single stent implanted lesion, lesion length no more than 28mm )

• IVUS available lesions

• Non-emergent conditions

• Patients confirmed about study enrollment and 9 month followup angiogram and IVUS

Exclusion Criteria:

Lesion & Procedural exclusion criteria

• IVUS unavailable lesion

• Restenotic lesions following PCI of de novo lesion like as below;

• left main lesions

• BMS restenotic lesion

• vein graft lesion

• Restenotic lesions following 2.25mm DES implantation

• Prior history of repeat DES implantation for DES restenosis (only conventional or cutting ballooning treatment for DES restenosis is included in this study)

• Simultaneous implantation of different types of DES on restenotic or another de novo lesions (Only same DES implantation is allowed on the restenotic or another de novo lesions)

• Patients with little possibility of performing follow-up angiogram and IVUS

General exclusion criteria

• Contraindication to anti-platelet agents & Bleeding history within prior 3 months

• Prior history or current presentation of DES thrombosis

• Age over 80 years

• Known hypersensitivity or contraindication to any of the following medications:

Heparin, Aspirin, Clopidogrel, Zotarolimus, Everolimus

• Severe hepatic dysfunction (3 times normal reference values)

• Serum creatinine level over 2.0 mg/dL or end-stage renal diseases on dialysis

• LVEF less than 30%

• Pregnant women or women with potential childbearing

• An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 9 months

• Life expectancy 1 year

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• In-stent Arterial Restenosis

Intervention

Device:
• Xiene V stent, Endeavor Resolute stent
for each lesion, randomized either Xience V stent or Endeavor Resolute stent

Locations

Country	Name	City	State
Korea, Republic of	Yousei Universty Healthcare System	Seoul

Sponsors (28)

Lead Sponsor

Collaborator

Korea University Anam Hospital

Bucheon Sejong Hospital, Busan University Medical Center, Catholic Medical Center, Chonnam National University, Chung-Ang University, Chungnam National University, Daegoo Catholic Medical College, Dankook University, Dong-A University, Eulji University, Hallym University Medical Center, Inje Univerisity Medical Center, Kangwon University Medical Center, Korea University Guro Hospital, Kunyang University Medical center, Kwandong Univerisity Medical Center, Kwangjoo Veteran Hospital, Kyemyeong Univerisity Medical Center, Kyungbook Univeristy Medical Center, Kyunghee University Medical Center, Seoul National University Medical Center, Suncheonyang University Medical Center, Sunkyungwan Univeristy Medical Center, Wonkwang University Medical Center, Yongnam University Medical Center, Yonsei University, Yonsei University Wonju Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent neointimal volume index		9 months on IVUS	No
Secondary	Major adverse cardiovascular events	Safety end-point; to evaluate the procedural success and the incidence of 12-month death, MI, target-vessel failure (TVF), or stent thrombosis	12 months	Yes
Secondary	Efficacy end-point	Efficacy end-point; to evaluate the 9-month binary angiographic restenosis (=50 percent in-stent diameter stenosis) and late loss, vascular remodeling during follow-up	9 months	No