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
1 other identifier
interventional
450
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2010
Typical duration for phase_4
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 17, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 22, 2010
June 1, 2010
1.6 years
June 17, 2010
June 17, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Target lesion revascularization rate
1 year
Secondary Outcomes (7)
Technical success
Initial
Angiographic restenosis
9 months
Target vessel revascularization
1 year
Target lesion revascularization
2 year
Target vessel revascularization
2 year
- +2 more secondary outcomes
Study Arms (1)
Single arm study
EXPERIMENTALInterventions
Everolimus-eluting stent implantation in patients with long coronary artery disease
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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) -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
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
Study Officials
- PRINCIPAL INVESTIGATOR
Yuji Oikawa, MD, PhD
Cardiovascular institute hospital
- PRINCIPAL INVESTIGATOR
Kenya Nasu, MD
Toyohashi Heart Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
June 17, 2010
First Posted
June 22, 2010
Study Start
February 1, 2010
Primary Completion
September 1, 2011
Study Completion
December 1, 2012
Last Updated
June 22, 2010
Record last verified: 2010-06