Long Coronary Artery Disease Clinical Trial
— XILLIONOfficial title:
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.
| Status | Enrolling by invitation |
| Enrollment | 450 |
| Est. completion date | December 2012 |
| Est. primary completion date | September 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
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) - |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Abashiri Kosei General Hospital | Abashiri | Hokkaido |
| Japan | Ayase Heart Hospital | Adachi | Tokyo |
| Japan | Juntendo University Hospital | Bunkyo | Tokyo |
| Japan | Engaru-Kosei General Hospital | Engaru | Hokkaido |
| Japan | Saiseikai Fukuoka General Hospital | Fukuoka | |
| Japan | Hakodate Goryokaku Hospital | Hakodate | Hokkaido |
| Japan | Itabashi Chuo Medical Center | Itabashi | Tokyo |
| Japan | Rinku General Medical Center | Izumiotsu | Osaka |
| Japan | Shinko Kakogawa Hospital | Kakogawa | Hyogo |
| Japan | Kasukabe Chuo General Hospital | Kasukabe | Saitama |
| Japan | Shuwa General Hospital | Kasukabe | Saitama |
| Japan | Tokyo-kita Social Insurance Hospital | Kita | Tokyo |
| Japan | Kokura memorial hospital | Kitakyushu | Fukuoka |
| Japan | Hoshi General Hospital | Koriyama | Fukushima |
| Japan | Miyagi Cardiovascular & Respiratory Center | Kurihara | Miyagi |
| Japan | Kusatsu Heart Center | Kusatsu | Shiga |
| Japan | Gunma Prefectural Cardiovascular Center | Maebashi | Gunma |
| Japan | Matsumoto Kyoritsu Hospital | Matsumoto | Nagano |
| Japan | Cardiovascular Institute Hospital | Minato-ku | Tokyo |
| Japan | Japanese Red Cross Nagoya Daiichi Hospital | Nagoya | Aichi |
| Japan | Obihiro National Hospital | Obihiro | Hokkaido |
| Japan | Sakurabashi Watanabe Hospital | Osaka | |
| Japan | Kinikyo Chuo Hospital | Sapporo | Hokkaido |
| Japan | Sapporo Orthopaedic Cardiovascular Hospital | Sapporo | Hokkaido |
| Japan | JR Tokyo General Hospital | Shibuya | Tokyo |
| Japan | Tokyo Medical University Hospital | Shinjuku | Tokyo |
| Japan | Tokyo Metropolitan Police Hospital | Tokyo | |
| Japan | Higashi Cardiovascular clinic | Toyohashi | Aichi |
| Japan | Toyohashi Heart Center | Toyohashi | Aichi |
| Japan | Daini Okamoto Hospital | Uji | Kyoto |
| Japan | Hiraka General Hospital | Yokote | Akita |
| Lead Sponsor | Collaborator |
|---|---|
| Society for Advancement of Coronary Intervention Research |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Target lesion revascularization rate | 1 year | Yes | |
| Secondary | Technical success | Initial | Yes | |
| Secondary | Angiographic restenosis | 9 months | Yes | |
| Secondary | Target vessel revascularization | 1 year | Yes | |
| Secondary | Target lesion revascularization | 2 year | Yes | |
| Secondary | Target vessel revascularization | 2 year | Yes | |
| Secondary | Incidences of acute, sub acute, and late stent thrombosis | 2 year | Yes | |
| Secondary | Incidence of MACCE | defined as cardiac death, nonfatal acute myocardial infarction and cerebrovascular events | 2 year | Yes |