Xience/Promus for Long Coronary Lesion Registry

Phase 4

• Conditions: Long Coronary Artery Disease
• Interventions: Device: Intracoronary stent implantation

• Registration Number: NCT01147237
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Status Verified: 2010-06
• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-06-17
• Last Update Submitted: 2010-06-17
• Study First Posted: 2010-06-22
• Last Update Posted: 2010-06-22
• Primary Completion: 2011-09
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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) -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm study	Intracoronary stent implantation	-

Primary Outcome Measures

Name	Time	Method
Target lesion revascularization rate	1 year

Secondary Outcome Measures

Name	Time	Method
Technical success	Initial
Angiographic restenosis	9 months
Target vessel revascularization	2 year
Target lesion revascularization	2 year
Incidences of acute, sub acute, and late stent thrombosis	2 year
Incidence of MACCE	2 year	defined as cardiac death, nonfatal acute myocardial infarction and cerebrovascular events

Trial Locations

Locations (31)

JR Tokyo General Hospital; 🇯🇵 Shibuya, Tokyo, Japan

Tokyo Medical University Hospital; 🇯🇵 Shinjuku, Tokyo, Japan

Itabashi Chuo Medical Center; 🇯🇵 Itabashi, Tokyo, Japan

Ayase Heart Hospital; 🇯🇵 Adachi, Tokyo, Japan

Juntendo University Hospital; 🇯🇵 Bunkyo, Tokyo, Japan

Tokyo-kita Social Insurance Hospital; 🇯🇵 Kita, Tokyo, Japan

Cardiovascular Institute Hospital; 🇯🇵 Minato-ku, Tokyo, Japan

Hakodate Goryokaku Hospital; 🇯🇵 Hakodate, Hokkaido, Japan

Kinikyo Chuo Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Sapporo Orthopaedic Cardiovascular Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Shuwa General Hospital; 🇯🇵 Kasukabe, Saitama, Japan

Toyohashi Heart Center; 🇯🇵 Toyohashi, Aichi, Japan

Japanese Red Cross Nagoya Daiichi Hospital; 🇯🇵 Nagoya, Aichi, Japan

Hoshi General Hospital; 🇯🇵 Koriyama, Fukushima, Japan

Engaru-Kosei General Hospital; 🇯🇵 Engaru, Hokkaido, Japan

Gunma Prefectural Cardiovascular Center; 🇯🇵 Maebashi, Gunma, Japan

Hiraka General Hospital; 🇯🇵 Yokote, Akita, Japan

Kokura memorial hospital; 🇯🇵 Kitakyushu, Fukuoka, Japan

Abashiri Kosei General Hospital; 🇯🇵 Abashiri, Hokkaido, Japan

Obihiro National Hospital; 🇯🇵 Obihiro, Hokkaido, Japan

Daini Okamoto Hospital; 🇯🇵 Uji, Kyoto, Japan

Saiseikai Fukuoka General Hospital; 🇯🇵 Fukuoka, Japan

Shinko Kakogawa Hospital; 🇯🇵 Kakogawa, Hyogo, Japan

Rinku General Medical Center; 🇯🇵 Izumiotsu, Osaka, Japan

Miyagi Cardiovascular ＆ Respiratory Center; 🇯🇵 Kurihara, Miyagi, Japan

Tokyo Metropolitan Police Hospital; 🇯🇵 Tokyo, Japan

Kasukabe Chuo General Hospital; 🇯🇵 Kasukabe, Saitama, Japan

Sakurabashi Watanabe Hospital; 🇯🇵 Osaka, Japan

Higashi Cardiovascular clinic; 🇯🇵 Toyohashi, Aichi, Japan

Kusatsu Heart Center; 🇯🇵 Kusatsu, Shiga, Japan

Matsumoto Kyoritsu Hospital; 🇯🇵 Matsumoto, Nagano, Japan