Xience/Promus for Long Coronary Lesion Registry (XILLION)

A Multi Center Registry to Evaluate Multiple Stenting Using by Everolimus-eluting Stents for Treatment of Long Coronary Artery Disease

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.

Study Overview

• Status: Unknown
• Conditions: Long Coronary Artery Disease
• Intervention / Treatment: Device: Intracoronary stent implantation

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
    • Saiseikai Fukuoka General Hospital
  • Osaka, Japan
    • Sakurabashi Watanabe Hospital
  • Tokyo, Japan
    • Tokyo Metropolitan Police Hospital
  • Aichi
    • Nagoya, Aichi, Japan
      • Japanese Red Cross Nagoya Daiichi Hospital
    • Toyohashi, Aichi, Japan, 4418530
      • Toyohashi Heart Center
    • Toyohashi, Aichi, Japan
      • Higashi Cardiovascular clinic
  • Akita
    • Yokote, Akita, Japan
      • Hiraka General Hospital
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan
      • Kokura Memorial Hospital
  • Fukushima
    • Koriyama, Fukushima, Japan
      • Hoshi general hospital
  • Gunma
    • Maebashi, Gunma, Japan
      • Gunma prefectural cardiovascular center
  • Hokkaido
    • Abashiri, Hokkaido, Japan
      • Abashiri Kosei General Hospital
    • Engaru, Hokkaido, Japan
      • Engaru-Kosei General Hospital
    • Hakodate, Hokkaido, Japan
      • Hakodate Goryokaku Hospital
    • Obihiro, Hokkaido, Japan
      • Obihiro National Hospital
    • Sapporo, Hokkaido, Japan
      • Kinikyo Chuo Hospital
    • Sapporo, Hokkaido, Japan
      • Sapporo Orthopaedic Cardiovascular Hospital
  • Hyogo
    • Kakogawa, Hyogo, Japan
      • Shinko kakogawa hospital
  • Kyoto
    • Uji, Kyoto, Japan
      • Daini Okamoto Hospital
  • Miyagi
    • Kurihara, Miyagi, Japan
      • Miyagi Cardiovascular ＆ Respiratory Center
  • Nagano
    • Matsumoto, Nagano, Japan
      • Matsumoto Kyoritsu Hospital
  • Osaka
    • Izumiotsu, Osaka, Japan
      • Rinku General Medical Center
  • Saitama
    • Kasukabe, Saitama, Japan
      • Kasukabe Chuo General Hospital
    • Kasukabe, Saitama, Japan
      • Shuwa General Hospital
  • Shiga
    • Kusatsu, Shiga, Japan
      • Kusatsu Heart Center
  • Tokyo
    • Adachi, Tokyo, Japan
      • Ayase heart hospital
    • Bunkyo, Tokyo, Japan
      • Juntendo University Hospital
    • Itabashi, Tokyo, Japan
      • Itabashi Chuo Medical Center
    • Kita, Tokyo, Japan
      • Tokyo-kita Social Insurance Hospital
    • Minato-ku, Tokyo, Japan, 1060032
      • Cardiovascular institute hospital
    • Shibuya, Tokyo, Japan
      • JR Tokyo General Hospital
    • Shinjuku, Tokyo, Japan
      • Tokyo Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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) -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single arm study	Device: Intracoronary stent implantation; Everolimus-eluting stent implantation in patients with long coronary artery disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Target lesion revascularization rate	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target vessel revascularization		1 year
Technical success		Initial
Angiographic restenosis		9 months
Target lesion revascularization		2 year
Target vessel revascularization		2 year
Incidences of acute, sub acute, and late stent thrombosis		2 year
Incidence of MACCE	defined as cardiac death, nonfatal acute myocardial infarction and cerebrovascular events	2 year

Collaborators and Investigators

• Sponsor: Society for Advancement of Coronary Intervention Research
• Investigators: Principal Investigator: Yuji Oikawa, MD, PhD, Cardiovascular institute hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ANTICIPATED): September 1, 2011
• Study Completion (ANTICIPATED): December 1, 2012

Study Registration Dates

• First Submitted: June 17, 2010
• First Submitted That Met QC Criteria: June 17, 2010
• First Posted (ESTIMATE): June 22, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 22, 2010
• Last Update Submitted That Met QC Criteria: June 17, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: XILLION