Clinical trial NCT01147237: Xience/Promus for Long Coronary Lesion Registry
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Long Coronary Artery Disease
Lead sponsor: Society for Advancement of Coronary Intervention Research
Sponsor class: NETWORK
First posted: 2010-06-22
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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) -

Primary outcomes:
measure: Target lesion revascularization rate
timeFrame: 1 year
Secondary outcomes:
measure: Technical success
timeFrame: Initial
measure: Angiographic restenosis
timeFrame: 9 months
measure: Target vessel revascularization
timeFrame: 1 year
measure: Target lesion revascularization
timeFrame: 2 year
measure: Target vessel revascularization
timeFrame: 2 year
measure: Incidences of acute, sub acute, and late stent thrombosis
timeFrame: 2 year
measure: Incidence of MACCE
timeFrame: 2 year
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Japanese Red Cross Nagoya Daiichi Hospital
state: Aichi
city: Toyohashi
country: Japan
facility: Toyohashi Heart Center
state: Aichi
city: Toyohashi
country: Japan
facility: Higashi Cardiovascular clinic
state: Aichi
city: Yokote
country: Japan
facility: Hiraka General Hospital
state: Akita
city: Kitakyushu
country: Japan
facility: Kokura memorial hospital
state: Fukuoka
city: Koriyama
country: Japan
facility: Hoshi General Hospital
state: Fukushima
city: Maebashi
country: Japan
facility: Gunma Prefectural Cardiovascular Center
state: Gunma
city: Abashiri
country: Japan
facility: Abashiri Kosei General Hospital
state: Hokkaido
city: Engaru
country: Japan
facility: Engaru-Kosei General Hospital
state: Hokkaido
city: Hakodate
country: Japan
facility: Hakodate Goryokaku Hospital
state: Hokkaido
city: Obihiro
country: Japan
facility: Obihiro National Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Kinikyo Chuo Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Orthopaedic Cardiovascular Hospital
state: Hokkaido
city: Kakogawa
country: Japan
facility: Shinko Kakogawa Hospital
state: Hyogo
city: Uji
country: Japan
facility: Daini Okamoto Hospital
state: Kyoto
city: Kurihara
country: Japan
facility: Miyagi Cardiovascular ＆ Respiratory Center
state: Miyagi
city: Matsumoto
country: Japan
facility: Matsumoto Kyoritsu Hospital
state: Nagano
city: Izumiotsu
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Kasukabe
country: Japan
facility: Kasukabe Chuo General Hospital
state: Saitama
city: Kasukabe
country: Japan
facility: Shuwa General Hospital
state: Saitama
city: Kusatsu
country: Japan
facility: Kusatsu Heart Center
state: Shiga
city: Adachi
country: Japan
facility: Ayase Heart Hospital
state: Tokyo
city: Bunkyo
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Itabashi
country: Japan
facility: Itabashi Chuo Medical Center
state: Tokyo
city: Kita
country: Japan
facility: Tokyo-kita Social Insurance Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Cardiovascular Institute Hospital
state: Tokyo
city: Shibuya
country: Japan
facility: JR Tokyo General Hospital
state: Tokyo
city: Shinjuku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Saiseikai Fukuoka General Hospital
city: Osaka
country: Japan
facility: Sakurabashi Watanabe Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Police Hospital
Study officials:
affiliation: Cardiovascular institute hospital
name: Yuji Oikawa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toyohashi Heart Center
name: Kenya Nasu, MD
role: PRINCIPAL_INVESTIGATOR
References: