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Xience/Promus for Long Coronary Lesion Registry (XILLION)

Primary Purpose

Long Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Intracoronary stent implantation
Sponsored by
Society for Advancement of Coronary Intervention Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Long Coronary Artery Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥20 years and are able to undergo CABG
  2. Females who are not pregnant
  3. Patients who present with angina symptoms or myocardial ischemia
  4. Patients available for post-procedural observation and coronary angiography at 24 months
  5. Patients who have signed patient informed consent
  6. Lesion length is more than 30mm
  7. De novo lesion or non-stented restenosed lesion

Exclusion Criteria:

  1. Patients contraindicated for antiplatelet therapy or anticoagulant therapy
  2. Patients with significant allergic reaction to contrast medium
  3. Chronic total occlusion
  4. Lesion with TIMI0
  5. Patients with chronic renal failure (SCr>3.0mg/dl) -

Sites / Locations

  • Japanese Red Cross Nagoya Daiichi Hospital
  • Toyohashi Heart Center
  • Higashi Cardiovascular clinic
  • Hiraka General Hospital
  • Kokura memorial hospital
  • Hoshi General Hospital
  • Gunma Prefectural Cardiovascular Center
  • Abashiri Kosei General Hospital
  • Engaru-Kosei General Hospital
  • Hakodate Goryokaku Hospital
  • Obihiro National Hospital
  • Kinikyo Chuo Hospital
  • Sapporo Orthopaedic Cardiovascular Hospital
  • Shinko Kakogawa Hospital
  • Daini Okamoto Hospital
  • Miyagi Cardiovascular ＆ Respiratory Center
  • Matsumoto Kyoritsu Hospital
  • Rinku General Medical Center
  • Kasukabe Chuo General Hospital
  • Shuwa General Hospital
  • Kusatsu Heart Center
  • Ayase Heart Hospital
  • Juntendo University Hospital
  • Itabashi Chuo Medical Center
  • Tokyo-kita Social Insurance Hospital
  • Cardiovascular Institute Hospital
  • JR Tokyo General Hospital
  • Tokyo Medical University Hospital
  • Saiseikai Fukuoka General Hospital
  • Sakurabashi Watanabe Hospital
  • Tokyo Metropolitan Police Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm study

Arm Description

Outcomes

Primary Outcome Measures

Target lesion revascularization rate

Secondary Outcome Measures

Technical success
Angiographic restenosis
Target vessel revascularization
Target lesion revascularization
Target vessel revascularization
Incidences of acute, sub acute, and late stent thrombosis
Incidence of MACCE
defined as cardiac death, nonfatal acute myocardial infarction and cerebrovascular events

Full Information

First Posted
June 17, 2010
Last Updated
June 17, 2010
Sponsor
Society for Advancement of Coronary Intervention Research
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1. Study Identification

Unique Protocol Identification Number
NCT01147237
Brief Title
Xience/Promus for Long Coronary Lesion Registry
Acronym
XILLION
Official Title
A Multi Center Registry to Evaluate Multiple Stenting Using by Everolimus-eluting Stents for Treatment of Long Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Society for Advancement of Coronary Intervention Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The utilization of everolimus-eluting coronary stents in a coronary artery diseases is effective in reducing both repeat revascularization and major adverse cardiac events within two year follow-up. To evaluate the procedural, short and long term clinical outcomes of multiple everolimus-eluting coronary stent implantation in long (>30mm) coronary lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm study
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Intracoronary stent implantation
Intervention Description
Everolimus-eluting stent implantation in patients with long coronary artery disease
Primary Outcome Measure Information:
Title
Target lesion revascularization rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Technical success
Time Frame
Initial
Title
Angiographic restenosis
Time Frame
9 months
Title
Target vessel revascularization
Time Frame
1 year
Title
Target lesion revascularization
Time Frame
2 year
Title
Target vessel revascularization
Time Frame
2 year
Title
Incidences of acute, sub acute, and late stent thrombosis
Time Frame
2 year
Title
Incidence of MACCE
Description
defined as cardiac death, nonfatal acute myocardial infarction and cerebrovascular events
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥20 years and are able to undergo CABG Females who are not pregnant Patients who present with angina symptoms or myocardial ischemia Patients available for post-procedural observation and coronary angiography at 24 months Patients who have signed patient informed consent Lesion length is more than 30mm De novo lesion or non-stented restenosed lesion Exclusion Criteria: Patients contraindicated for antiplatelet therapy or anticoagulant therapy Patients with significant allergic reaction to contrast medium Chronic total occlusion Lesion with TIMI0 Patients with chronic renal failure (SCr>3.0mg/dl) -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuji Oikawa, MD, PhD
Organizational Affiliation
Cardiovascular institute hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenya Nasu, MD
Organizational Affiliation
Toyohashi Heart Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Japanese Red Cross Nagoya Daiichi Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Toyohashi Heart Center
City
Toyohashi
State/Province
Aichi
ZIP/Postal Code
4418530
Country
Japan
Facility Name
Higashi Cardiovascular clinic
City
Toyohashi
State/Province
Aichi
Country
Japan
Facility Name
Hiraka General Hospital
City
Yokote
State/Province
Akita
Country
Japan
Facility Name
Kokura memorial hospital
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
Hoshi General Hospital
City
Koriyama
State/Province
Fukushima
Country
Japan
Facility Name
Gunma Prefectural Cardiovascular Center
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
Abashiri Kosei General Hospital
City
Abashiri
State/Province
Hokkaido
Country
Japan
Facility Name
Engaru-Kosei General Hospital
City
Engaru
State/Province
Hokkaido
Country
Japan
Facility Name
Hakodate Goryokaku Hospital
City
Hakodate
State/Province
Hokkaido
Country
Japan
Facility Name
Obihiro National Hospital
City
Obihiro
State/Province
Hokkaido
Country
Japan
Facility Name
Kinikyo Chuo Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Sapporo Orthopaedic Cardiovascular Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Shinko Kakogawa Hospital
City
Kakogawa
State/Province
Hyogo
Country
Japan
Facility Name
Daini Okamoto Hospital
City
Uji
State/Province
Kyoto
Country
Japan
Facility Name
Miyagi Cardiovascular ＆ Respiratory Center
City
Kurihara
State/Province
Miyagi
Country
Japan
Facility Name
Matsumoto Kyoritsu Hospital
City
Matsumoto
State/Province
Nagano
Country
Japan
Facility Name
Rinku General Medical Center
City
Izumiotsu
State/Province
Osaka
Country
Japan
Facility Name
Kasukabe Chuo General Hospital
City
Kasukabe
State/Province
Saitama
Country
Japan
Facility Name
Shuwa General Hospital
City
Kasukabe
State/Province
Saitama
Country
Japan
Facility Name
Kusatsu Heart Center
City
Kusatsu
State/Province
Shiga
Country
Japan
Facility Name
Ayase Heart Hospital
City
Adachi
State/Province
Tokyo
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo
State/Province
Tokyo
Country
Japan
Facility Name
Itabashi Chuo Medical Center
City
Itabashi
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo-kita Social Insurance Hospital
City
Kita
State/Province
Tokyo
Country
Japan
Facility Name
Cardiovascular Institute Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
1060032
Country
Japan
Facility Name
JR Tokyo General Hospital
City
Shibuya
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjuku
State/Province
Tokyo
Country
Japan
Facility Name
Saiseikai Fukuoka General Hospital
City
Fukuoka
Country
Japan
Facility Name
Sakurabashi Watanabe Hospital
City
Osaka
Country
Japan
Facility Name
Tokyo Metropolitan Police Hospital
City
Tokyo
Country
Japan

12. IPD Sharing Statement

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Xience/Promus for Long Coronary Lesion Registry

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