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

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 )

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01365572

Acronym

Restenosis

Enrollment

292

Registered

2011-06-03

Start date

2010-01-31

Completion date

2012-03-31

Last updated

2011-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In-stent Arterial Restenosis

Keywords

Drug-eluting stent

Brief 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

Interventions

DEVICEXiene V stent, Endeavor Resolute stent

for each lesion, randomized either Xience V stent or Endeavor Resolute stent

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
In-stent neointimal volume index	9 months on IVUS

Secondary

Measure	Time frame	Description
Major adverse cardiovascular events	12 months	Safety end-point; to evaluate the procedural success and the incidence of 12-month death, MI, target-vessel failure (TVF), or stent thrombosis
Efficacy end-point	9 months	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

Countries

South Korea

Contacts

Primary ContactKorea University Anam Hospital Ahn, MD, PhD

drcello@kumc.or.kr+82-2-920-5445

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026