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Xience/Promus for Long Coronary Lesion Registry (XILLION)

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ClinicalTrials.gov Identifier: NCT01147237
Recruitment Status : Unknown
Verified June 2010 by Society for Advancement of Coronary Intervention Research.
Recruitment status was:  Enrolling by invitation
First Posted : June 22, 2010
Last Update Posted : June 22, 2010
Sponsor:
Information provided by:
Society for Advancement of Coronary Intervention Research

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.

Condition or disease Intervention/treatment Phase
Long Coronary Artery Disease Device: Intracoronary stent implantation Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi Center Registry to Evaluate Multiple Stenting Using by Everolimus-eluting Stents for Treatment of Long Coronary Artery Disease
Study Start Date : February 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single arm study Device: Intracoronary stent implantation
Everolimus-eluting stent implantation in patients with long coronary artery disease




Primary Outcome Measures :
  1. Target lesion revascularization rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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 [ Time Frame: 2 year ]
    defined as cardiac death, nonfatal acute myocardial infarction and cerebrovascular events



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01147237


Locations
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Japan
Japanese Red Cross Nagoya Daiichi Hospital
Nagoya, Aichi, Japan
Toyohashi Heart Center
Toyohashi, Aichi, Japan, 4418530
Higashi Cardiovascular clinic
Toyohashi, Aichi, Japan
Hiraka General Hospital
Yokote, Akita, Japan
Kokura memorial hospital
Kitakyushu, Fukuoka, Japan
Hoshi General Hospital
Koriyama, 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, Hyogo, Japan
Daini Okamoto Hospital
Uji, Kyoto, Japan
Miyagi Cardiovascular & Respiratory Center
Kurihara, Miyagi, Japan
Matsumoto Kyoritsu Hospital
Matsumoto, Nagano, Japan
Rinku General Medical Center
Izumiotsu, 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, Tokyo, Japan
Juntendo University Hospital
Bunkyo, Tokyo, Japan
Itabashi Chuo Medical Center
Itabashi, Tokyo, Japan
Tokyo-kita Social Insurance Hospital
Kita, Tokyo, Japan
Cardiovascular Institute Hospital
Minato-ku, Tokyo, Japan, 1060032
JR Tokyo General Hospital
Shibuya, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku, Tokyo, Japan
Saiseikai Fukuoka General Hospital
Fukuoka, Japan
Sakurabashi Watanabe Hospital
Osaka, Japan
Tokyo Metropolitan Police Hospital
Tokyo, Japan
Sponsors and Collaborators
Society for Advancement of Coronary Intervention Research
Investigators
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Principal Investigator: Yuji Oikawa, MD, PhD Cardiovascular institute hospital
Principal Investigator: Kenya Nasu, MD Toyohashi Heart Center

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Responsible Party: Kenya Nasu, Toyohashi Heart Center
ClinicalTrials.gov Identifier: NCT01147237     History of Changes
Other Study ID Numbers: XILLION
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: June 2010
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs