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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01500434




Registration number
NCT01500434
Ethics application status
Date submitted
22/12/2011
Date registered
28/12/2011

Titles & IDs
Public title
The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions (PLATINUM LL)
Scientific title
PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions - Long Lesion Sub-trial
Secondary ID [1] 0 0
S2046C
Universal Trial Number (UTN)
Trial acronym
PLATINUM LL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - PROMUS Element Coronary Stent System
Treatment: Drugs - Aspirin
Treatment: Drugs - Thienopyridine

Experimental: PROMUS Element - Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent


Treatment: Devices: PROMUS Element Coronary Stent System
PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).

Treatment: Drugs: Aspirin
Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.

Treatment: Drugs: Thienopyridine
Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Target Lesion Failure (TLF)
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Target Lesion Failure (TLF)
Timepoint [1] 0 0
30 Days
Secondary outcome [2] 0 0
Target Lesion Failure (TLF)
Timepoint [2] 0 0
6 Months
Secondary outcome [3] 0 0
Target Vessel Failure (TVF)
Timepoint [3] 0 0
30 Days
Secondary outcome [4] 0 0
Target Vessel Failure (TVF)
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Target Vessel Failure (TVF)
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
All Cause Death
Timepoint [6] 0 0
30 Days
Secondary outcome [7] 0 0
All Cause Death
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
All Cause Death
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Cardiac Death Related to the Target Vessel
Timepoint [9] 0 0
30 Days
Secondary outcome [10] 0 0
Cardiac Death Related to the Target Vessel
Timepoint [10] 0 0
6 months
Secondary outcome [11] 0 0
Cardiac Death Related to the Target Vessel
Timepoint [11] 0 0
12 months
Secondary outcome [12] 0 0
Myocardial Infarction (MI) Related to the Target Vessel
Timepoint [12] 0 0
30 Days
Secondary outcome [13] 0 0
Myocardial Infarction (MI) Related to the Target Vessel
Timepoint [13] 0 0
6 months
Secondary outcome [14] 0 0
Myocardial Infarction (MI) Related to the Target Vessel
Timepoint [14] 0 0
12 months
Secondary outcome [15] 0 0
Target Lesion Revascularization (TLR)
Timepoint [15] 0 0
30 days
Secondary outcome [16] 0 0
Target Lesion Revascularization (TLR)
Timepoint [16] 0 0
6 months
Secondary outcome [17] 0 0
Target Lesion Revascularization (TLR)
Timepoint [17] 0 0
12 months
Secondary outcome [18] 0 0
Target Vessel Revascularization (TVR)
Timepoint [18] 0 0
30 days
Secondary outcome [19] 0 0
Target Vessel Revascularization (TVR)
Timepoint [19] 0 0
6 months
Secondary outcome [20] 0 0
Target Vessel Revascularization (TVR)
Timepoint [20] 0 0
12 months
Secondary outcome [21] 0 0
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
Timepoint [21] 0 0
24 hours
Secondary outcome [22] 0 0
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
Timepoint [22] 0 0
>24 hours-30 days
Secondary outcome [23] 0 0
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
Timepoint [23] 0 0
31-365 days
Secondary outcome [24] 0 0
Acute Technical Success
Timepoint [24] 0 0
Index Procedure
Secondary outcome [25] 0 0
Clinical Procedural Success
Timepoint [25] 0 0
In hospital (average of 1-2 days post index procedure)

Eligibility
Key inclusion criteria
* Patient must be at least 18 years of age
* Patient (or legal guardian) understands study requirements and treatment procedures and provides written informed consent before any study-specific tests or procedures are performed
* For patients less than 20 years of age enrolled at a Japanese site, patient and patient's legal representative must provide 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 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 evaluations

Angiographic Inclusion Criteria (visual estimate):

- Target lesion must be a de novo lesion >24 mm and =34 mm in length (by visual estimate) in a native coronary artery =2.50 mm to =4.25 mm in diameter (by visual estimate). 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI
* Patient has had a known diagnosis of recent MI (ie, within 72 hours prior to index procedure) and has elevated enzymes at time of index procedure as follows.

* Patients are excluded if any of the following criteria are met at time of the index procedure.

* If CK-MB >2× upper limit of normal (ULN), the patient is excluded regardless of 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 time of index procedure.

* Troponin >1× ULN with at least one of the following.
* Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (eg, >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/randomizing 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 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 (eg, 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 platelet count <100,000 cells/mm3 or >700,000 cells/mm3
* Patient has 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 (ie, estimated creatinine clearance <50 ml/min by the Cockcroft Gault formula, or [(140-age)*lean body weight (in kg)]/[plasma creatinine (mg/dl)*72])
* Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
* Target vessel(s) or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to index procedure
* Target vessel(s) has been treated within 10 mm proximal or distal to target lesion (by visual estimate) with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to 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 index procedure
* Planned or actual target vessel(s) 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 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 (eg, 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 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 index procedure
* Patient with known intention to procreate within 12 months after 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 2 target lesions, or more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure

Angiographic Exclusion Criteria (visual estimate):

* Target lesion meets any of the following criteria:

* Aorto-ostial location (ie, lesion located within 5 mm of ostium by visual estimate)
* Left main location
* Located within 5 mm of origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate
* Located within a saphenous vein graft or arterial graft
* Will be accessed via a saphenous vein graft or arterial graft
* Involves a side branch >=2.0 mm in diameter by visual estimate
* Involves a clinically significant side branch <2.0 mm in diameter by visual estimate 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 by visual estimate
* Restenotic from previous intervention
* Thrombus, or possible thrombus, present in target vessel
* Non-target lesion to be treated during the index procedure meets any of the following criteria:

* Located within the target vessel
* Located within a bypass graft (venous or arterial)
* Left main location
* Chronic total occlusion
* Involves a complex bifurcation (eg, bifurcations requiring treatment with more than 1 stent)
* Restenotic from previous intervention
* Patient has unprotected left main coronary artery disease (>50% diameter stenosis)
* Patient has protected left main coronary artery disease and a target lesion in the LAD or LCX
* Patient has an additional clinically significant lesion(s) in target vessel for which an intervention within 12 months after the index procedure is likely to be required
* Patient has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate) Note: Multiple focal stenoses will be considered as a single lesion if they can be completely covered with 1 stent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
St. Vincents Public, - Fitzroy
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Maine
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Mississippi
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Belgium
State/province [15] 0 0
Genk
Country [16] 0 0
Belgium
State/province [16] 0 0
Leuven
Country [17] 0 0
France
State/province [17] 0 0
Toulouse
Country [18] 0 0
Japan
State/province [18] 0 0
Kanagawa-ken
Country [19] 0 0
Japan
State/province [19] 0 0
Osaka
Country [20] 0 0
Latvia
State/province [20] 0 0
Riga
Country [21] 0 0
New Zealand
State/province [21] 0 0
Takapuna

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter M. Maurer, MPH
Address 0 0
Boston Scientific Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01500434