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Status unknownNCT01147237XILLIONUpdated Jun 22, 2010

Xience/Promus for Long Coronary Lesion Registry

A Phase 4 interventional study of Intracoronary stent implantation in Long Coronary Artery Disease, sponsored by Society for Advancement of Coronary Intervention Research. Status unknown at 31 sites in Japan. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-06-22.

Sponsored by Society for Advancement of Coronary Intervention Research · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2010), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
450
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

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Conditions studied

  • Long Coronary Artery Disease
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In context

Lead sponsor

Society for Advancement of Coronary Intervention Research is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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) -
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
450 participants (actual)

Study arms

  • Experimental
    Single arm study

    Device: Intracoronary stent implantation

Interventions

  • DeviceIntracoronary stent implantation

    Everolimus-eluting stent implantation in patients with long coronary artery disease

06

What researchers measure

Primary outcomes

  1. Target lesion revascularization rate

    Time frame: 1 year

Secondary outcomes

  1. Technical success

    Time frame: Initial

  2. Angiographic restenosis

    Time frame: 9 months

  3. Target vessel revascularization

    Time frame: 1 year

  4. Target lesion revascularization

    Time frame: 2 year

  5. Target vessel revascularization

    Time frame: 2 year

  6. Incidences of acute, sub acute, and late stent thrombosis

    Time frame: 2 year

  7. Incidence of MACCE

    defined as cardiac death, nonfatal acute myocardial infarction and cerebrovascular events

    Time frame: 2 year

07

Study locations

31 sites
  • Japanese Red Cross Nagoya Daiichi Hospital
    Nagoya, Aichi-ken, Japan
  • Toyohashi Heart Center
    Toyohashi, Aichi-ken 4418530, Japan
  • Higashi Cardiovascular clinic
    Toyohashi, Aichi-ken, Japan
  • Hiraka General Hospital
    Yokote, Akita, Japan
  • Saiseikai Fukuoka General Hospital
    Fukuoka, Fukuoka, Japan
  • Kokura memorial hospital
    Kitakyushu, Fukuoka, Japan
  • Hoshi General Hospital
    Kōriyama, Fukushima, Japan
  • Gunma Prefectural Cardiovascular Center
    Maebashi, Gunma, Japan
  • Abashiri Kosei General Hospital
    Abashiri, Hokkaido, Japan
  • Engaru-Kosei General Hospital
    Engaru, Hokkaido, Japan
  • Hakodate Goryokaku Hospital
    Hakodate, Hokkaido, Japan
  • Obihiro National Hospital
    Obihiro, Hokkaido, Japan
  • Kinikyo Chuo Hospital
    Sapporo, Hokkaido, Japan
  • Sapporo Orthopaedic Cardiovascular Hospital
    Sapporo, Hokkaido, Japan
  • Shinko Kakogawa Hospital
    Kakogawa, Hyōgo, Japan
  • Daini Okamoto Hospital
    Uji, Kyoto, Japan
  • Miyagi Cardiovascular ＆ Respiratory Center
    Kurihara, Miyagi, Japan
  • Matsumoto Kyoritsu Hospital
    Matsumoto, Nagano, Japan
  • Rinku General Medical Center
    Izumiōtsu, Osaka, Japan
  • Sakurabashi Watanabe Hospital
    Osaka, Osaka, Japan
  • Kasukabe Chuo General Hospital
    Kasukabe, Saitama, Japan
  • Shuwa General Hospital
    Kasukabe, Saitama, Japan
  • Kusatsu Heart Center
    Kusatsu, Shiga, Japan
  • Ayase Heart Hospital
    Adachi City, Tokyo, Japan
  • Juntendo University Hospital
    Bunkyo, Tokyo, Japan
  • Tokyo-kita Social Insurance Hospital
    Kita-ku, Tokyo, Japan
  • Cardiovascular Institute Hospital
    Minato-ku, Tokyo 1060032, Japan
  • JR Tokyo General Hospital
    Shibuya City, Tokyo, Japan
  • Tokyo Medical University Hospital
    Shinjuku, Tokyo, Japan
  • Itabashi Chuo Medical Center
    tabashi City, Tokyo, Japan
  • Tokyo Metropolitan Police Hospital
    Tokyo, Tokyo, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01147237
Lead sponsor
Society for Advancement of Coronary Intervention Research
First posted
Jun 22, 2010
Start date
Feb 2010
Primary completion
Sep 2011 (estimated)
Completion
Dec 2012 (estimated)
Last update
Jun 22, 2010

Study contacts

Yuji Oikawa, MD, PhD
principal investigator · Cardiovascular institute hospital
Kenya Nasu, MD
principal investigator · Toyohashi Heart Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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