Xience/Promus for Long Coronary Lesion Registry

NCT ID: NCT01147237

Last Updated: 2010-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Long Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm study

Group Type EXPERIMENTAL

Intracoronary stent implantation

Intervention Type DEVICE

Everolimus-eluting stent implantation in patients with long coronary artery disease

Interventions

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Intracoronary stent implantation

Everolimus-eluting stent implantation in patients with long coronary artery disease

Intervention Type DEVICE

Eligibility Criteria

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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) -
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Society for Advancement of Coronary Intervention Research

NETWORK

Sponsor Role lead

Responsible Party

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Toyohashi Heart Center

Principal Investigators

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Yuji Oikawa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular institute hospital

Kenya Nasu, MD

Role: PRINCIPAL_INVESTIGATOR

Toyohashi Heart Center

Locations

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Japanese Red Cross Nagoya Daiichi Hospital

Nagoya, Aichi-ken, Japan

Site Status

Toyohashi Heart Center

Toyohashi, Aichi-ken, Japan

Site Status

Higashi Cardiovascular clinic

Toyohashi, Aichi-ken, Japan

Site Status

Hiraka General Hospital

Yokote, Akita, Japan

Site Status

Saiseikai Fukuoka General Hospital

Fukuoka, Fukuoka, Japan

Site Status

Kokura memorial hospital

Kitakyushu, Fukuoka, Japan

Site Status

Hoshi General Hospital

Kōriyama, Fukushima, Japan

Site Status

Gunma Prefectural Cardiovascular Center

Maebashi, Gunma, Japan

Site Status

Abashiri Kosei General Hospital

Abashiri, Hokkaido, Japan

Site Status

Engaru-Kosei General Hospital

Engaru, Hokkaido, Japan

Site Status

Hakodate Goryokaku Hospital

Hakodate, Hokkaido, Japan

Site Status

Obihiro National Hospital

Obihiro, Hokkaido, Japan

Site Status

Kinikyo Chuo Hospital

Sapporo, Hokkaido, Japan

Site Status

Sapporo Orthopaedic Cardiovascular Hospital

Sapporo, Hokkaido, Japan

Site Status

Shinko Kakogawa Hospital

Kakogawa, Hyōgo, Japan

Site Status

Daini Okamoto Hospital

Uji, Kyoto, Japan

Site Status

Miyagi Cardiovascular & Respiratory Center

Kurihara, Miyagi, Japan

Site Status

Matsumoto Kyoritsu Hospital

Matsumoto, Nagano, Japan

Site Status

Rinku General Medical Center

Izumiōtsu, Osaka, Japan

Site Status

Sakurabashi Watanabe Hospital

Osaka, Osaka, Japan

Site Status

Kasukabe Chuo General Hospital

Kasukabe, Saitama, Japan

Site Status

Shuwa General Hospital

Kasukabe, Saitama, Japan

Site Status

Kusatsu Heart Center

Kusatsu, Shiga, Japan

Site Status

Ayase Heart Hospital

Adachi City, Tokyo, Japan

Site Status

Juntendo University Hospital

Bunkyo, Tokyo, Japan

Site Status

Tokyo-kita Social Insurance Hospital

Kita-ku, Tokyo, Japan

Site Status

Cardiovascular Institute Hospital

Minato-ku, Tokyo, Japan

Site Status

JR Tokyo General Hospital

Shibuya City, Tokyo, Japan

Site Status

Tokyo Medical University Hospital

Shinjuku, Tokyo, Japan

Site Status

Itabashi Chuo Medical Center

tabashi City, Tokyo, Japan

Site Status

Tokyo Metropolitan Police Hospital

Tokyo, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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XILLION

Identifier Type: -

Identifier Source: org_study_id

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