Coronary Artery DiseaseSPECIALISTNCT01670318
Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets
A study testing platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts) in people with Coronary Artery Disease, run by The PCI Guideline Research Society at 38 sites in Japan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 38 sitesJapan
- Study dates
- Aug 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome
- Male or non-pregnant female
- Key lesion inclusion criteria as follows
- Multi-vessel diseases
- Long lesion (lesion length >30mm by visual estimation)
- Small vessel disease (reference diameter <2.5mm by visual estimation)
Show all 12Show fewer
- Bifurcation lesion
- Ostial lesion
- Calcified lesion
- Protected or non-protected left main trunk disease
- Chronic total occlusion
- In stent restenosis of bare metal stent or everolimus-eluting stent
Who cannot join
- Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine, clopidogrel or X-ray contrast media.
- Serum creatinine level >3.0 mg/dL
- Other concomitant disease or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis or cancer within 5 years.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
Japan38 sites, 38 recruiting
- Not yet recruiting
Ayase Heart Hospital
Adachi-ku, Tokyo, 120-0006
Hidenari Hozawa
Hidenari Hozawa, MD
- Not yet recruiting
Kansai Rosai Hospital
Amagasaki, Hyōgo, 660-8511
Masaki Awata
Masaki Awata, MD
- Not yet recruiting
Tokyo Rinkai Hospital
Edogawa-ku, Tokyo, 134-0086
Motoyuki Onikura
Motoyuki Onikura, MD
- Not yet recruiting
Megumino Hospital
Eniwa, Hokkaido, 061-1395
Noriko Makiguchi
Noriko Makiguchi, MD
- Not yet recruiting
Saiseikai Fukuoka General Hospital
Fukuoka, Fukuoka, 810-0001
Takeshi Serikawa
Takeshi Serikawa, MD
- Not yet recruiting
Seirei Mikatahara General Hospital
Hamamatsu, Shizuoka, 433-8558
Yasuyo Takeuchi
Yasuyo Takeuchi, MD
- Not yet recruiting
Itabashi Chuo Medical Center
Itabashi-ku, Tokyo, 174-0051
Hiroshi Ota
Hiroshi Ota, MD
- Not yet recruiting
Rinku General Medical Center
Izumisano, Osaka, 598-8577
Yoshihiro Takeda
Yoshihiro Takeda, MD
- Not yet recruiting
Kakogawa East City Hospital
Kakogawa, Hyōgo, 685-0115
Makoto Kadotani
Makoto Kadotani, MD
- Not yet recruiting
SHUWA General Hospital
Kasukabe, Saitama, 344-0035
Ryo Goto
Ryo Goto, MD
- Not yet recruiting
Kasukabe Chuo General Hospital
Kasukabe, Saitama, 344-0063
Satoru Tohara
Satoru Tohara, MD
- Not yet recruiting
Katsushika Medical Center
Katsushika-ku, Tokyo, 125-8506
Yoshiki Uehara
Yoshiki Uehara, MD
- Not yet recruiting
Tokyo-Kita Social Insurance Hospital
Kita-ku, Tokyo, 115-0053
Yuya Nakagawa
Yuya Nakagawa, MD
- Not yet recruiting
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555
Shinichi Shirai
Shinichi Shirai, MD
- Not yet recruiting
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Toshiro Shinke
Toshiro Shinke, MD
- Not yet recruiting
Hoshi General Hospital
Kōriyama, Fukushima, 963-8501
Yuichi Ujiie
Yuichi Ujiie, MD
- Not yet recruiting
Southern Tohoku Research Institute for Neuroscience
Kōriyama, Fukushima, 963-8563
Mitsuru Muto
Muto Mitsuru, MD
- Not yet recruiting
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861-4193
Eiji Taguchi
Eiji Taguchi, MD
- Not yet recruiting
Gunma Prefectural Cardiovascular Center
Maebashi, Gunma, 371-0004
Ren Kawaguchi
Ren Kawaguchi, MD
- Not yet recruiting
Gunma University Hospital
Maebashi, Gunma, 371-8511
Ryuichi Funada
Ryuichi Funada, MD
- Not yet recruiting
Matsumoto Kyoritsu Hospital
Matsumoto, Nagano, 390-8505
Hidetoshi Abe
Hidetoshi Abe, MD
- Not yet recruiting
The Cardiovascular Institute
Minato-ku, Tokyo, 106-0031
Yuji Oikawa
Yuji Oikawa, MD
- Not yet recruiting
JA Hokkaido Engaru Kosei General Hospital
Monbetsu, Hokkaido, 099-0404
Takahide Suzuki
Takahide Suzuki, MD
- Not yet recruiting
Aichi Medical University Hospital
Nagakute, Aichi-ken, 480-1195
Hiroaki Takashima
Hiroaki Takashima, MD
- Not yet recruiting
Tokyo Metropolitan Police Hospital
Nakano-ku, Tokyo, 164-8541
Masatoshi Suzuki
Masatoshi Suzuki, MD
- Not yet recruiting
Nayoro City General Hospital
Nayoro, Hokkaido, 096-8511
Masaru Yamaki
Masaru Yamaki, MD
- Not yet recruiting
Ota Memorial Hospital
Ōta, Gunma, 373-8585
Hidetoshi Anzai
Hidetoshi Anzai, MD
- Not yet recruiting
Sapporo Cardio Vascular Clinic
Sapporo, Hokkaido, 007-0849
Yoshifumi Kashima
Yoshifumi Kashima, MD
- Not yet recruiting
Tokyo Metropolitan Hiroo Hospital
Shibuya-ku, Tokyo, 150-0013
Yasuhiro Tanabe
Yasuhiro Tanabe, MD
- Not yet recruiting
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625
Masashiro Matsushita
Masashiro Matsushita, MD
- Not yet recruiting
Hokusetsu General Hospital
Takatsuki, Osaka, 569-0852
Wataru Nagamatsu
Wataru Nagamatsu, MD
- Not yet recruiting
TODA CHUO General Hospital
Toda, Saitama, 335-0023
Yuichi Kobori
Yuichi Kobori, MD
- Recruiting
Toyohashi Heart Center
Toyohashi, Aichi-ken, 441-8530
Kenya Nasu, MD
Kenya Nasu, MD
- Not yet recruiting
Tsukuba Medical Center Hospital
Tsukuba, Ibaragi, 305-8558
Hidetaka Nishina
Hidetaka Nishina, MD
- Not yet recruiting
Daini Okamoto General Hospital
Uji, Kyoto, 611-0025
Masaki Tanabe
Masaki Tanabe, MD
- Not yet recruiting
Juntendo University Urayasu Hospital
Urayasu, Chiba, 279-0021
Ken Yokoyama
Ken Tokoyama, MD
- Not yet recruiting
Yokohama Rosai Hospital
Yokohama, Kanagawa, 222-0036
Kazuhiko Yumoto
Kazuhiko YUmoto, MD
- Not yet recruiting
Yokohama City Minato Red Cross Hospital
Yokohama, Kanagawa, 231-8682
Tsukasa Shimura
Tsukasa Shimura, MD
About this study
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.
- Conditions
- Coronary Artery Disease
- Being tested
- platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)
- Keywords
- Chronic total occlusion, Bifurcation lesion, Left main trunk lesion, Small vessel disease, Multi vessel disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)Device
| Study group | Role | What they receive |
|---|---|---|
| platinum chromium everolimus-eluting stent | Experimental | Not described Receives: Device: platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization
Measured: 12 month
Secondary outcomes (7)
Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site
Measured: In hospital
Target lesion revascularization
Measured: 12 month
Target vessel revascularization
Measured: 12 month
Myocardial infarction
Measured: 24 month
Cardiac death
Measured: 24 month
Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization
Measured: 24 month
Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC)
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The PCI Guideline Research Society
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Yuji Oikawa, MD, PhD, Principal investigator, The Cardiovascular InstituteKenya Nasu, MD, FACC, Principal investigator, Toyohashi Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670318
- Sponsor's protocol ID
- SPECIALIST Registry
- Acronym
- SPECIALIST
- Status last verified
- Aug 2012
- First submitted
- 16 Aug 2012
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets
- ClinicalTrials.gov ID
- NCT01670318
- Acronym / sponsor ID
- SPECIALIST / SPECIALIST Registry
- Conditions
- Coronary Artery Disease
- Keywords
- Chronic total occlusion, Bifurcation lesion, Left main trunk lesion, Small vessel disease, Multi vessel disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- The PCI Guideline Research SocietyResearch network
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 22 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| platinum chromium everolimus-eluting stent | Experimental | Device: platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts) |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome
- Male or non-pregnant female
- Key lesion inclusion criteria as follows
Key exclusion criteria (3 listed)
- Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine, clopidogrel or X-ray contrast media.
- Serum creatinine level >3.0 mg/dL
- Other concomitant disease or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis or cancer within 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts) | Device | platinum chromium everolimus-eluting stent |
Primary outcome
Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization
Time frame: 12 month
7 secondary outcomes
Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site
Time frame: In hospital
Target lesion revascularization
Time frame: 12 month
Target vessel revascularization
Time frame: 12 month
Myocardial infarction
Time frame: 24 month
Cardiac death
Time frame: 24 month
Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization
Time frame: 24 month
Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC)
Time frame: 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2012.
Related trials for Coronary Artery Disease
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Active, not recruiting
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Coronary Artery Disease
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuji Oikawa, MD, PhD principal investigator
The Cardiovascular Institute
Kenya Nasu, MD, FACC principal investigator
Toyohashi Heart Center
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts) in people with Coronary Artery Disease, run by The PCI Guideline Research Society at 38 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenya Nasu, MD, FACC (+81532373377, yuyatomoya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2012.