Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets (SPECIALIST)

August 21, 2012 updated by: The PCI Guideline Research Society
Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left main trunk disease, and small vessel diseases is still unknown.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Japan
      • Fukuoka, Japan, 810-0001
        • Not yet recruiting
        • Saiseikai Fukuoka General Hospital
        • Contact:
          • Takeshi Serikawa
        • Principal Investigator:
          • Takeshi Serikawa, MD
      • Kumamoto, Japan, 861-4193
        • Not yet recruiting
        • Saiseikai Kumamoto Hospital
        • Contact:
          • Eiji Taguchi
        • Principal Investigator:
          • Eiji Taguchi, MD
    • Aichi
      • Nagakute, Aichi, Japan, 480-1195
        • Not yet recruiting
        • Aichi Medical University Hospital
        • Contact:
          • Hiroaki Takashima
        • Principal Investigator:
          • Hiroaki Takashima, MD
      • Toyohashi, Aichi, Japan, 441-8530
        • Recruiting
        • Toyohashi Heart Center
        • Contact:
          • Kenya Nasu, MD
        • Principal Investigator:
          • Kenya Nasu, MD
    • Chiba
      • Urayasu, Chiba, Japan, 279-0021
        • Not yet recruiting
        • Juntendo University Urayasu Hospital
        • Contact:
          • Ken Yokoyama
        • Principal Investigator:
          • Ken Tokoyama, MD
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 802-8555
        • Not yet recruiting
        • Kokura Memorial Hospital
        • Contact:
          • Shinichi Shirai
        • Principal Investigator:
          • Shinichi Shirai, MD
    • Fukushima
      • Koriyama, Fukushima, Japan, 963-8501
        • Not yet recruiting
        • Hoshi General Hospital
        • Contact:
          • Yuichi Ujiie
        • Sub-Investigator:
          • Yuichi Ujiie, MD
      • Koriyama, Fukushima, Japan, 963-8563
        • Not yet recruiting
        • Southern Tohoku Research Institute for Neuroscience
        • Contact:
          • Mitsuru Muto
        • Principal Investigator:
          • Muto Mitsuru, MD
    • Gunma
      • Maebashi, Gunma, Japan, 371-0004
        • Not yet recruiting
        • Gunma Prefectural Cardiovascular Center
        • Contact:
          • Ren Kawaguchi
        • Principal Investigator:
          • Ren Kawaguchi, MD
      • Maebashi, Gunma, Japan, 371-8511
        • Not yet recruiting
        • Gunma University Hospital
        • Contact:
          • Ryuichi Funada
        • Principal Investigator:
          • Ryuichi Funada, MD
      • Ota, Gunma, Japan, 373-8585
        • Not yet recruiting
        • Ota Memorial Hospital
        • Contact:
          • Hidetoshi Anzai
        • Principal Investigator:
          • Hidetoshi Anzai, MD
    • Hokkaido
      • Eniwa, Hokkaido, Japan, 061-1395
        • Not yet recruiting
        • Megumino Hospital
        • Contact:
          • Noriko Makiguchi
        • Principal Investigator:
          • Noriko Makiguchi, MD
      • Monbetsu, Hokkaido, Japan, 099-0404
        • Not yet recruiting
        • JA Hokkaido Engaru Kosei General Hospital
        • Contact:
          • Takahide Suzuki
        • Principal Investigator:
          • Takahide Suzuki, MD
      • Nayoro, Hokkaido, Japan, 096-8511
        • Not yet recruiting
        • Nayoro City General Hospital
        • Contact:
          • Masaru Yamaki
        • Principal Investigator:
          • Masaru Yamaki, MD
      • Sapporo, Hokkaido, Japan, 007-0849
        • Not yet recruiting
        • Sapporo Cardio Vascular Clinic
        • Contact:
          • Yoshifumi Kashima
        • Principal Investigator:
          • Yoshifumi Kashima, MD
    • Hyogo
      • Amagasaki, Hyogo, Japan, 660-8511
        • Not yet recruiting
        • Kansai Rosai Hospital
        • Contact:
          • Masaki Awata
        • Principal Investigator:
          • Masaki Awata, MD
      • Kakogawa, Hyogo, Japan, 685-0115
        • Not yet recruiting
        • Kakogawa East City Hospital
        • Contact:
          • Makoto Kadotani
        • Principal Investigator:
          • Makoto Kadotani, MD
      • Kobe, Hyogo, Japan, 650-0017
        • Not yet recruiting
        • Kobe University Hospital
        • Contact:
          • Toshiro Shinke
        • Principal Investigator:
          • Toshiro Shinke, MD
    • Ibaragi
      • Tsukuba, Ibaragi, Japan, 305-8558
        • Not yet recruiting
        • Tsukuba Medical Center Hospital
        • Contact:
          • Hidetaka Nishina
        • Principal Investigator:
          • Hidetaka Nishina, MD
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 222-0036
        • Not yet recruiting
        • Yokohama Rosai Hospital
        • Contact:
          • Kazuhiko Yumoto
        • Principal Investigator:
          • Kazuhiko YUmoto, MD
      • Yokohama, Kanagawa, Japan, 231-8682
        • Not yet recruiting
        • Yokohama City Minato Red Cross Hospital
        • Contact:
          • Tsukasa Shimura
        • Principal Investigator:
          • Tsukasa Shimura, MD
    • Kyoto
      • Uji, Kyoto, Japan, 611-0025
        • Not yet recruiting
        • Daini Okamoto General Hospital
        • Contact:
          • Masaki Tanabe
        • Principal Investigator:
          • Masaki Tanabe, MD
    • Nagano
      • Matsumoto, Nagano, Japan, 390-8505
        • Not yet recruiting
        • Matsumoto Kyoritsu Hospital
        • Contact:
          • Hidetoshi Abe
        • Principal Investigator:
          • Hidetoshi Abe, MD
    • Osaka
      • Izumisano, Osaka, Japan, 598-8577
        • Not yet recruiting
        • Rinku General Medical Center
        • Contact:
          • Yoshihiro Takeda
        • Principal Investigator:
          • Yoshihiro Takeda, MD
      • Takatsuki, Osaka, Japan, 569-0852
        • Not yet recruiting
        • Hokusetsu General Hospital
        • Contact:
          • Wataru Nagamatsu
        • Principal Investigator:
          • Wataru Nagamatsu, MD
    • Saitama
      • Kasukabe, Saitama, Japan, 344-0035
        • Not yet recruiting
        • Shuwa General Hospital
        • Contact:
          • Ryo Goto
        • Principal Investigator:
          • Ryo Goto, MD
      • Kasukabe, Saitama, Japan, 344-0063
        • Not yet recruiting
        • Kasukabe Chuo General Hospital
        • Contact:
          • Satoru Tohara
        • Principal Investigator:
          • Satoru Tohara, MD
      • Toda, Saitama, Japan, 335-0023
        • Not yet recruiting
        • TODA CHUO General Hospital
        • Contact:
          • Yuichi Kobori
        • Principal Investigator:
          • Yuichi Kobori, MD
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 433-8558
        • Not yet recruiting
        • Seirei Mikatahara General Hospital
        • Contact:
          • Yasuyo Takeuchi
        • Principal Investigator:
          • Yasuyo Takeuchi, MD
    • Tokyo
      • Adachi-ku, Tokyo, Japan, 120-0006
        • Not yet recruiting
        • Ayase heart hospital
        • Contact:
          • Hidenari Hozawa
        • Principal Investigator:
          • Hidenari Hozawa, MD
      • Edogawa-ku, Tokyo, Japan, 134-0086
        • Not yet recruiting
        • Tokyo Rinkai Hospital
        • Contact:
          • Motoyuki Onikura
        • Principal Investigator:
          • Motoyuki Onikura, MD
      • Itabashi-ku, Tokyo, Japan, 174-0051
        • Not yet recruiting
        • Itabashi Chuo Medical Center
        • Contact:
          • Hiroshi Ota
        • Principal Investigator:
          • Hiroshi Ota, MD
      • Katsushika-ku, Tokyo, Japan, 125-8506
        • Not yet recruiting
        • Katsushika Medical Center
        • Contact:
          • Yoshiki Uehara
        • Principal Investigator:
          • Yoshiki Uehara, MD
      • Kita-ku, Tokyo, Japan, 115-0053
        • Not yet recruiting
        • Tokyo-kita Social Insurance Hospital
        • Contact:
          • Yuya Nakagawa
        • Principal Investigator:
          • Yuya Nakagawa, MD
      • Minato-ku, Tokyo, Japan, 106-0031
        • Not yet recruiting
        • The Cardiovascular Institute
        • Contact:
          • Yuji Oikawa
        • Principal Investigator:
          • Yuji Oikawa, MD
      • Nakano-ku, Tokyo, Japan, 164-8541
        • Not yet recruiting
        • Tokyo Metropolitan Police Hospital
        • Contact:
          • Masatoshi Suzuki
        • Principal Investigator:
          • Masatoshi Suzuki, MD
      • Shibuya-ku, Tokyo, Japan, 150-0013
        • Not yet recruiting
        • Tokyo Metropolitan Hiroo Hospital
        • Contact:
          • Yasuhiro Tanabe
        • Principal Investigator:
          • Yasuhiro Tanabe, MD
      • Shinagawa-ku, Tokyo, Japan, 141-8625
        • Not yet recruiting
        • NTT Medical Center Tokyo
        • Contact:
          • Masashiro Matsushita
        • Principal Investigator:
          • Masashiro Matsushita, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome
  2. Male or non-pregnant female

  3. Key lesion inclusion criteria as follows

    1. Multi-vessel diseases
    2. Long lesion (lesion length >30mm by visual estimation)
    3. Small vessel disease (reference diameter <2.5mm by visual estimation)
    4. Bifurcation lesion
    5. Ostial lesion
    6. Calcified lesion
    7. Protected or non-protected left main trunk disease
    8. Chronic total occlusion
    9. In stent restenosis of bare metal stent or everolimus-eluting stent

Exclusion Criteria:

  1. Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine, clopidogrel or X-ray contrast media.
  2. Serum creatinine level >3.0 mg/dL
  3. Other concomitant disease or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis or cancer within 5 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: platinum chromium everolimus-eluting stent
Device: platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization
Time Frame: 12 month
12 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site
Time Frame: In hospital
In hospital
Target lesion revascularization
Time Frame: 12 month
12 month
Target vessel revascularization
Time Frame: 12 month
12 month
Myocardial infarction
Time Frame: 24 month
24 month
Cardiac death
Time Frame: 24 month
24 month
Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization
Time Frame: 24 month
24 month
Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC)
Time Frame: 24 month
24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The PCI Guideline Research Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuji Oikawa, MD, PhD, The Cardiovascular Institute
  • Principal Investigator: Kenya Nasu, MD, FACC, Toyohashi Heart Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPECIALIST Registry

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings