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AtherosclerosisPhase 3NCT01080261

PROMUS Element Japan Small Vessel Trial

A Phase 3 study testing PROMUS Element in people with Atherosclerosis and Coronary Artery Disease, run by Boston Scientific Corporation at 15 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A non-randomized, small vessel (SV) trial at approximately 15 sites in Japan to enroll 60 patients with a de novo lesion ≤28 mm in length (by visual estimate) in a native coronary artery ≥2.25 mm to <2.50 mm in diameter (by visual estimate). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Atherosclerosis, Coronary Artery Disease
What is being tested?
PROMUS Element
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
15 sitesJapan
Study dates
Feb 2010to Dec 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must be at least 20 years of age
  • Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed
  • Patient is eligible for percutaneous coronary intervention (PCI) with regards to the target lesion Patient is considered suitable for PCI if any of the following criteria meet.
  • Evidence of ischemia documented with stress electrocardiogram (ECG) and/or any diagnostic imaging tests.
  • Target vessel supplies blood to relatively large area of the myocardium.
  • Target lesion is a possible culprit of angina.
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  • Target vessel is a potential collateral source for other major vessels
  • Patient has documented stable angina pectoris or documented silent ischemia; or unstable angina pectoris
  • Patient is an acceptable candidate for coronary artery bypass grafting (CABG)
  • Patient has a left ventricular ejection fraction (LVEF) ≥30% as measured within 30 days prior to enrollment
  • Patient is willing to comply with all protocol-required follow-up evaluation

Who cannot join

  • Patient has clinical symptoms and/or ECG changes consistent with acute myocardial infarction (MI)
  • Patient has had a known diagnosis of recent MI (i.e., within 72 hours prior to the index procedure) and has elevated enzymes at the time of the index procedure as follows.
  • Patients are excluded if any of the following criteria are met at the time of the index procedure.
  • If creatine kinase-myoglobin band (CK-MB) is >2× upper limit of normal (ULN), the patient is excluded regardless of the CK Total.
  • If CK MB is 1 2× ULN, the patient is excluded if the CK Total is >2× ULN.
  • If CK Total/CK MB are not used and Troponin is, patients are excluded if the following criterion is met at the time of the index procedure.
Show all 38Show fewer
  • Troponin >1× ULN with at least one of the following.
  • Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (e.g., >1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block [LBBB]);
  • Development of pathological Q waves in the ECG; or
  • Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
  • Note: For patients with unstable angina or patients who have had a recent MI, CK Total/CK MB (or Troponin if CK Total/CK MB are not used) must be documented prior to enrolling the patient.
  • Patient has received an organ transplant or is on a waiting list for an organ transplant
  • Patient is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
  • Patient is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
  • Patient is receiving chronic (≥72 hours) anticoagulation therapy (e.g., heparin, warfarin) for indications other than acute coronary syndrome
  • Patient has a platelet count <100,000 cells/mm^3 or >700,000 cells/mm^3
  • Patient has a white blood cell (WBC) count <3,000 cells/mm^3
  • Patient has documented or suspected liver disease, including laboratory evidence of hepatitis
  • Patient is on dialysis or has known renal insufficiency (i.e., Creatinine > 2.0 mg/dl or >150 μmol/L)
  • Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
  • Target vessel or side branch has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure (excluding PCI of the non-target lesion within the target vessel treated during the index procedure (Refer to Multiple Interventions During Index Procedure))
  • Target vessel has been treated within 10 mm proximal or distal to the target lesion (by visual estimate) with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to the index procedure
  • Non-target vessel or side branch has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to the index procedure
  • Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement
  • Planned PCI or CABG after the index procedure
  • Patient previously treated at any time with coronary intravascular brachytherapy
  • Patient has a known allergy to the study stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated
  • Patient has an active peptic ulcer or active gastrointestinal (GI) bleeding
  • Patient has one of the following.
  • Other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 24 months
  • Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
  • Planned procedure that may cause non-compliance with the protocol or confound data interpretation
  • Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
  • Patient intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
  • Patient with known intention to procreate within 12 months after the index procedure (Women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.)
  • Patient is a woman who is pregnant or nursing (A pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential.)
  • Patient has more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Japan15 sites

  • Hakodate Municipal Hospital

    Hakodate-shi, Hokkaido

  • Shonan Kamakura General Hospital

    Kamakura-shi, Kanagawa

  • Japan Labour Health and Welfare Organization Kanto Rosai Hospital

    Kawasaki-shi, Kanagawa

  • Kokura Memorial Hospital

    Kitakyushu-shi, Fukuoka

  • Hoshi General Hospital

    Koriyama-shi, Fukushima

  • Kurashiki Central Hospital

    Kurashiki-shi, Okayama-ken

  • Kyoto-Katsura Hospital

    Kyoto, Kyoto

  • Toho University Ohashi Medical Center

    Meguro-ku, Tokyo-tu

  • The Cardiovascular Institute Hospital

    Minatoku, Tokyo-to

  • Hokkaido Social Insurance Hospital

    Sapporo, Hokkaido

  • Jichi Medical University Hospital

    Shimotsuke-shi, Tochigi

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo-to

  • Japan Labour Health and Welfare Organization Kumamoto Rosai Hospital

    Yatsushiro-shi, Kumamoto

  • Saiseikai Yokohama-City Eastern Hospital

    Yokohama, Kanagawa

  • Yokohama City University Hospital

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Prospective Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of a Small Vessel De Novo Coronary Artery Lesion in Japan

A non-randomized, small vessel (SV) trial at approximately 15 sites in Japan to enroll 60 patients with a de novo lesion ≤28 mm in length (by visual estimate) in a native coronary artery ≥2.25 mm to <2.50 mm in diameter (by visual estimate). Approximately thirty patients will be randomly assigned to the angiographic subset to also undergo angiographic assessment after the 12-month clinical follow-up.

Being tested
PROMUS Element
Keywords
Atherosclerosis, Coronary Artery Disease
Medical subject headings
Atherosclerosis, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PROMUS ElementDevice

    PROMUS Element Everolimus-Eluting Coronary Stent System

Study groups in NCT01080261
Study groupRoleWhat they receive
PROMUS ElementExperimentaleverolimus-eluting coronary stent
Receives: Device: PROMUS Element

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Cardiac Events (MACE) (Percentage of Participants With an Event)

    A major adverse cardiac event (MACE) is defined as any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI, Q-wave and non-Q-wave), or cardiac death. Reported as percentage of participants who have experienced a MACE event.

    Measured: 9 months

Secondary outcomes (11)

  1. Myocardial Infarction (MI) (Percentage of Participants With an Event)

    New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB) or troponin above upper limit of normal (ULN) (baseline troponin <ULN); if no new Q-waves total CK or troponin >3× ULN (baseline troponin <ULN) plus at least one of the following: electrocardiogram changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5× ULN

    Measured: 9 months

  2. All-cause Death (Percentage of Participants With an Event)

    Participants who died from any cause

    Measured: 9 months

  3. Cardiac Death (Percentage of Participants With an Event)

    Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded. Reported as percentage of participants who experienced cardiac death.

    Measured: 9 months

  4. Target Vessel Revascularization (Percentage of Participants With an Event)

    Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.Reported as percentage of participants who experienced a TVR.

    Measured: 9 months

  5. Target Lesion Revascularization (Percentage of Participants With an Event)

    Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. Reported as percentage of participants who experienced a TLR.

    Measured: 9 months

  6. Target Vessel Failure (TVF) (Percentage of Participants With an Event)

    Includes any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. Reported as percentage of participants who experienced a TVF event.

    Measured: 9 months

  7. Target Lesion Failure (TLF) (Percentage of Participants With an Event)

    Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. Reported as percentage of participants who experienced a TLF event.

    Measured: 9 months

  8. Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event)

    DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)

    Measured: 0-30 Days (Early)

  9. Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event)

    DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)

    Measured: >30 days - 9 months

  10. Technical Success (Percentage of Stents)

    Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent

    Measured: At time of index procedure

  11. Clinical Procedural Success (Percentage of Participants)

    Expressed as percentage of participants in whom mean lesion diameter stenosis was <30% with TIMI 3 flow (visually assessed) and who did not experience an occurrence of in-hospital myocardial infarction, target vessel revascularization, or cardiac death.

    Measured: While participant is in the hospital

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionMar 2011
  4. Study completionDec 2012

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01080261
Sponsor's protocol ID
S2069
Status last verified
Aug 2012
First submitted
2 Mar 2010
Last updated
29 Mar 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PROMUS Element in people with Atherosclerosis and Coronary Artery Disease, run by Boston Scientific Corporation at 15 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 11 inclusion and 38 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: finished, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiac Events (MACE) (Percentage of Participants With an Event) (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01080261.

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 29 Mar 2016.

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PROMUS Element Japan Small Vessel Trial (NCT01080261) | AzTrials