Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by The PCI Guideline Research Society.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
The PCI Guideline Research Society
ClinicalTrials.gov Identifier:
NCT01670318
First received: August 16, 2012
Last updated: August 21, 2012
Last verified: August 2012
  Purpose
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.

Condition Intervention
Coronary Artery Disease
Device: platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets

Resource links provided by NLM:


Further study details as provided by The PCI Guideline Research Society:

Primary Outcome Measures:
  • Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site [ Time Frame: In hospital ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Target vessel revascularization [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Myocardial infarction [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • Cardiac death [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC) [ Time Frame: 24 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: platinum chromium everolimus-eluting stent Device: platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670318

Locations
Japan
Aichi Medical University Hospital
Nagakute, Aichi, Japan, 480-1195
Toyohashi Heart Center
Toyohashi, Aichi, Japan, 441-8530
Juntendo University Urayasu Hospital
Urayasu, Chiba, Japan, 279-0021
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan, 802-8555
Hoshi General Hospital
Koriyama, Fukushima, Japan, 963-8501
Southern Tohoku Research Institute for Neuroscience
Koriyama, Fukushima, Japan, 963-8563
Gunma Prefectural Cardiovascular Center
Maebashi, Gunma, Japan, 371-0004
Gunma University Hospital
Maebashi, Gunma, Japan, 371-8511
Ota Memorial Hospital
Ota, Gunma, Japan, 373-8585
Megumino Hospital
Eniwa, Hokkaido, Japan, 061-1395
JA Hokkaido Engaru Kosei General Hospital
Monbetsu, Hokkaido, Japan, 099-0404
Nayoro City General Hospital
Nayoro, Hokkaido, Japan, 096-8511
Sapporo Cardio Vascular Clinic
Sapporo, Hokkaido, Japan, 007-0849
Kansai Rosai Hospital
Amagasaki, Hyogo, Japan, 660-8511
Kakogawa East City Hospital
Kakogawa, Hyogo, Japan, 685-0115
Kobe University Hospital
Kobe, Hyogo, Japan, 650-0017
Tsukuba Medical Center Hospital
Tsukuba, Ibaragi, Japan, 305-8558
Yokohama Rosai Hospital
Yokohama, Kanagawa, Japan, 222-0036
Yokohama City Minato Red Cross Hospital
Yokohama, Kanagawa, Japan, 231-8682
Daini Okamoto General Hospital
Uji, Kyoto, Japan, 611-0025
Matsumoto Kyoritsu Hospital
Matsumoto, Nagano, Japan, 390-8505
Rinku General Medical Center
Izumisano, Osaka, Japan, 598-8577
Hokusetsu General Hospital
Takatsuki, Osaka, Japan, 569-0852
SHUWA General Hospital
Kasukabe, Saitama, Japan, 344-0035
Kasukabe Chuo General Hospital
Kasukabe, Saitama, Japan, 344-0063
TODA CHUO General Hospital
Toda, Saitama, Japan, 335-0023
Seirei Mikatahara General Hospital
Hamamatsu, Shizuoka, Japan, 433-8558
Ayase Heart Hospital
Adachi-ku, Tokyo, Japan, 120-0006
Tokyo Rinkai Hospital
Edogawa-ku, Tokyo, Japan, 134-0086
Itabashi Chuo Medical Center
Itabashi-ku, Tokyo, Japan, 174-0051
Katsushika Medical Center
Katsushika-ku, Tokyo, Japan, 125-8506
Tokyo-Kita Social Insurance Hospital
Kita-ku, Tokyo, Japan, 115-0053
The Cardiovascular Institute
Minato-ku, Tokyo, Japan, 106-0031
Tokyo Metropolitan Police Hospital
Nakano-ku, Tokyo, Japan, 164-8541
Tokyo Metropolitan Hiroo Hospital
Shibuya-ku, Tokyo, Japan, 150-0013
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, Japan, 141-8625
Saiseikai Fukuoka General Hospital
Fukuoka, Japan, 810-0001
Saiseikai Kumamoto Hospital
Kumamoto, Japan, 861-4193
Sponsors and Collaborators
The PCI Guideline Research Society
Investigators
Principal Investigator: Yuji Oikawa, MD, PhD The Cardiovascular Institute
Principal Investigator: Kenya Nasu, MD, FACC Toyohashi Heart Center
  More Information

Responsible Party: The PCI Guideline Research Society
ClinicalTrials.gov Identifier: NCT01670318     History of Changes
Other Study ID Numbers: SPECIALIST Registry 
Study First Received: August 16, 2012
Last Updated: August 21, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by The PCI Guideline Research Society:
Chronic total occlusion
Bifurcation lesion
Left main trunk lesion
Small vessel disease
Multi vessel disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Chromium
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on December 02, 2016