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PLATINUM Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions-Pharmacokinetics (PLATINUM PK) | Clinical Trials | Clareo Health

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PLATINUM Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions-Pharmacokinetics (PLATINUM PK)

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 - Pharmacokinetics Sub-trial

NCT01510327•Boston Scientific Corporation

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. The lesions are located in vessels that are average-sized.

Detailed Description

The wide-spread use of drug-eluting stents (DES) has evolved as standard of care in de novo lesions. The proposed study will evaluate the safety and effectiveness of PROMUS Element for the treatment of de novo atherosclerotic lesions in native coronary arteries. The study design is consistent with the draft guidance for industry titled, "Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies" (March 2008). During the trial, thienopyridines must be administered according to the 2007 American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines, which recommended that clopidogrel (75 mg daily) or ticlopidine (250 mg twice daily) be prescribed after stent implantation for at least 6 months in all patients, and for at least 12 months in patients who are not at high risk of bleeding. For sites in the United States, the use of prasugrel is not allowed as part of the PLATINUM Clinical Trial. For sites in other countries, prasugrel may be prescribed according to its approved dosing in countries in which it is available. For patients taking aspirin daily a loading dose is recommended; for patients who have not been taking aspirin daily, aspirin must be administered as a loading dose. Patients continue to take aspirin indefinitely to reduce the risk of thrombosis. This PLATINUM Pharmacokinetics (PK) study is a sub-trial associated with the PLATINUM Workhorse Randomized Controlled Trial, which is registered under NCT00823212. PLATINUM PK was designed to evaluate the elution of everolimus from the PROMUS Element everolimus-eluting stent.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
•Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) \>=2.50 mm and \<=4.25 mm. Target lesion length must measure (by visual estimate) \<=24 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.

Exclusion Criteria

•Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (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 creatine kinase-myoglobin band(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.
+53 more criteria

Locations (5)

Medical Center of the Rockies (Loveland)

Loveland, Colorado, United States

Cardiac & Vascular Research Center of Northern Michigan

Petoskey, Michigan, United States

Saiseikai Yokohama-City Eastern Hospital

Yokohama, Kanagawa, Japan

Sakakibara Heart Institute, Japan Research Promotion Society for Cardiovascular Diseases

Fuchu-shi, Tokyo, Japan

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo-to, Japan

Key Dates

Start Date

October 1, 2009

Primary Completion Date

February 1, 2010

Completion Date

May 1, 2015

Last Updated

March 26, 2019

Enrollment

ACTUAL participants

Conditions

Coronary Artery Disease

Interventions

PROMUS Element Everolimus-Eluting Coronary Stent System

DEVICE

Aspirin

DRUG

Thienopyridine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 26, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

PLATINUM Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions-Pharmacokinetics (PLATINUM PK)

Inclusion Criteria

Exclusion Criteria

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