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AtherosclerosisPhase 3PLATINUM QCANCT00824434

A Prospective, Multi-center Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™)

A Phase 3 study testing PROMUS Element™ in people with Atherosclerosis and Coronary Artery Disease, run by Boston Scientific Corporation at 17 sites in 4 countries.

Completed

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

Official record
Search all trials

Trial summary

Compile acute (30-day) clinical outcomes data and 9-month angiographic and intravascular ultrasound (IVUS) data for the PROMUS Element™ Everolimus- Eluting Coronary Stent System in the treatment of patients with a single de novo atherosclerotic lesion Read more about this study

Who is it for?
Ages 18 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
100 participants
Where
17 sitesin 4 countries
Study dates
Mar 2009to Aug 2010
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient (or legal guardian) 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)
  • Patient has documented stable angina pectoris (Canadian Cardiovascular Society [CCS] Classification 1, 2, 3, or 4) or documented silent ischemia; or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C)
  • 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 specified follow-up evaluations
Show all 10Show fewer
  • Angiographic Inclusion Criteria:
  • Target lesion must be a de novo lesion located in a native coronary artery with visually estimated diameter of >=2.25 mm and <=4.25 mm
  • Target lesion length must measure (by visual estimate) <=34 mm
  • Target lesion must be in a major coronary artery or branch with visually estimated stenosis >=50% and <100% with Thrombolysis in Myocardial Infarction (TIMI) flow >1.

Who cannot join

  • Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (MI)
  • Patient has had a known diagnosis of recent MI (within 30 days 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, MB band (CK-MB) >2× upper limit of normal (ULN), the patient is excluded regardless of the creatine kinase (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, the patients are excluded if the following criterion is met at the time of the index procedure.
Show all 55Show fewer
  • Troponin >1× ULN with at least one of the following.
  • Patient has ischemic symptoms and electrocardiogram (ECG) changes indicative of ongoing ischemia (e.g., >1mm ST segment elevation or depression in consecutive leads or new left bundle branch block [LBBB]);
  • Development of pathological Q-waves in the ECG
  • Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
  • Note: For 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 (ie, 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 (eg, heparin, coumadin) for indications other than acute coronary syndrome
  • Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
  • Patient has a white blood cell (WBC) count <3,000 cells/mm3
  • Patient has documented or suspected liver disease, including laboratory evidence of hepatitis
  • Patient is on dialysis or has known renal insufficiency (i.e., estimated creatinine clearance <50 mL/min by the Cockcroft Gault formula, ie [(140-age)*lean body weight (in kg)]/[plasma creatinine (mg/dL)*72])
  • 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 percutaneous coronary intervention (PCI; eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the 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 (eg, 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 (eg, 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 percutaneous coronary intervention or coronary artery bypass grafting 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, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated
  • Patient has active peptic ulcer or active gastrointestinal (GI) bleeding
  • Patient has one of the following:
  • Other serious medical illness (eg, cancer, congestive heart failure) that may reduce life expectancy to less than 24 months
  • Current problems with substance abuse (eg, 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
  • Known intention to procreate within 12 months after the index procedure
  • Female with positive pregnancy test within 7 days prior to the index procedure (a pregnancy test must be performed in women of child-bearing potential prior to enrollment), or lactating
  • Patient has more than 1 target lesion or more than 1 target lesion and 1 non-target lesion, identified during screening for intervention
  • Angiographic Exclusion Criteria:
  • Target lesion meets any of the following criteria:
  • Aorto-ostial location (i.e., lesion located within 5 mm of the ostium)
  • Left main location
  • Located within 5 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery
  • Located within a saphenous vein graft or an arterial graft
  • Can only be accessed via a saphenous vein graft or an arterial graft
  • Involves a side branch >=2.0 mm in diameter
  • Involves a clinically significant side branch <2.0 mm in diameter that has a clinically significant stenosis at the ostium
  • TIMI flow 0 (total occlusion) or TIMI flow 1 prior to wire crossing
  • Excessive tortuosity proximal to or within the lesion
  • Extreme angulation proximal to or within the lesion
  • Target lesion and/or target vessel proximal to the target lesion is moderately to severely calcified
  • Restenotic from previous intervention
  • Thrombus, or possible thrombus, present in the target vessel
  • Patient has an additional clinically significant lesion(s) in the target vessel for which an intervention within 12 months after the index procedure is likely to be required

Trial locations and contacts

17 sites in 4 countries.

17 sites in 4 countries

Australia9 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • The Prince Charles Hospital

    Brisbane, 4032

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • St. Vincent's Hospital - Sydney

    Darlinghurst, New South Wales, 2010

  • St. Vincent Hospital (Melbourne)

    Fitzroy, Victoria, 3065

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

  • Liverpool Hospital

    Liverpool, 2170

  • Sir Charles Gairdner Hospital

    Perth, 6009

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

New Zealand5 sites

  • Christchurch Hospital

    Christchurch, 8001

  • Dunedin Hospital

    Dunedin, 9001

  • Middlemore Hospital

    Otahuhu, Auckland

  • North Shore Hospital

    Takapuna, Auckland, 0622

  • Wellington Hospital

    Wellington

Other trials in New Zealand

Singapore2 sites

  • National University Hospital, Singapore

    Singapore, Singapore, 119074

  • National Heart Centre Singapore

    Singapore, Singapore, 168752

Other trials in Singapore

Malaysia1 site

  • Institut Jantung Negara

    Kuala Lumpur, 50400

Other trials in Malaysia

About this study

Compile acute (30-day) clinical outcomes data and 9-month angiographic and intravascular ultrasound (IVUS) data for the PROMUS Element™ Everolimus- Eluting Coronary Stent System in the treatment of patients with a single de novo atherosclerotic lesion

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 Element™Device

    Drug eluting coronary stent system

Study groups in NCT00824434
Study groupRoleWhat they receive
Experimental StentExperimentalNot described
Receives: Device: PROMUS Element™

What is being measured

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

  1. Cardiac Events (Composite)

    Percentage of patients who had a myocardial infarction, cardiac death, target lesion revascularization, or stent thrombosis (defined as definite or probable per the Academic Research Consortium [ARC] definitions); see below for definitions of individual components.

    Measured: 30 days

Secondary outcomes (15)

  1. In-stent Late Loss

    In-stent late loss by quantitative coronary angiography in workhorse target lesions (visual reference vessel diameter [RVD] ≥2.5 mm and ≤4.25 mm and visual lesion length ≤24 mm)

    Measured: 9 months

  2. Occurance of Post-procedure Incomplete Stent Apposition

    Percentage of participants who experience incomplete stent apposition as determined immediately post-procedure by intravascular ultrasound

    Measured: Post-procedure

  3. Myocardial Infarction (MI)

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

    Measured: 12 months

  4. All-cause Mortality

    Measured: 12 months

  5. Target Lesion Revascularization (TLR)

    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.

    Measured: 30 Days

  6. Target Lesion Revascularization (TLR)

    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.

    Measured: 12 Months

  7. Target Vessel Revascularization (TVR)

    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.

    Measured: 30 Days

  8. Target Vessel Revascularization (TVR)

    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.

    Measured: 12 months

  9. Target Lesion Failure (TLF)

    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.

    Measured: 12 months

  10. Target Vessel Failure (TVF)

    Target vessel failure (TVF) is defined as 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.

    Measured: 12 months

  11. Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition

    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: 24 hours

  12. Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition

    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: >24 hr-30 days

  13. Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition

    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-1 year

  14. Clinical Procedural Success

    Mean lesion diameter stenosis < 30% with TIMI 3 flow without the occurrence of in-hospital cardiac death, MI, or TVR

    Measured: Duration of hospital stay (usually 1-2 days)

  15. Technical Success

    Successful delivery and deployment of the study stent to the target lesion, without balloon rupture or embolization, summarized per stent.

    Measured: Acute-At time of index procedure

Timeline

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

  1. First posted16 Jan 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionSep 2009
  4. Study completionAug 2010

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
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00824434
Sponsor's protocol ID
S2051
Acronym
PLATINUM QCA
Status last verified
Aug 2012
First submitted
15 Jan 2009
Last updated
30 Aug 2012
Data monitoring committee
Yes

Publications

  • Meredith IT, Whitbourn R, Scott D, El-Jack S, Zambahari R, Stone GW, Teirstein PS, Starzyk RM, Allocco DJ, Dawkins KD. PLATINUM QCA: a prospective, multicentre study assessing clinical, angiographic, and intravascular ultrasound outcomes with the novel platinum chromium thin-strut PROMUS Element everolimus-eluting stent in de novo coronary stenoses. EuroIntervention. 2011 May;7(1):84-90. doi: 10.4244/EIJV7I1A15.

    PubMed 21550907

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 17 sites in 4 countries.

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 10 inclusion and 55 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 30 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 17 sites in Australia, New Zealand, Singapore, Malaysia. 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 7 Mar 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?

Cardiac Events (Composite) (time frame: 30 days). 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 NCT00824434, which also lists 1 linked publication.

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 30 Aug 2012.

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