PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study (PE-Prove)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Pharmaceutical Research Associates, Inc.
Medidata Solutions
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01148329
First received: June 21, 2010
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.


Condition Intervention
Coronary Heart Disease
Device: Coronary stenting

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the PROMUS™ Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Target Vessel Failure (TVF) [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Overall and PROMUS™ Element™ stent related TVF rate (cardiac death, myocardial infarction (MI) related to target vessel and target vessel re-intervention (TVR)) at 12 months post stent implantation.


Secondary Outcome Measures:
  • Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR) [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    Overall and PROMUS™ Element™ stent-related MACE rates (cardiac death, MI, TVR).

  • Death or MI rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    Overall and PROMUS™ Element™ stent-related cardiac death or MI rates

  • TVR rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: No ]
    Overall and PROMUS™ Element™ stent-related TVR rates.

  • Cardiac death rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    Overall and PROMUS™ Element™ stent-related cardiac death rates.

  • MI Rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    Overall and PROMUS™ Element™ stent-related MI rates.

  • All death rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    All death rates

  • Non-cardiac death rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    Non-cardiac death rates

  • All death or MI rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    All death and MI rates


Enrollment: 1010
Study Start Date: June 2010
Estimated Study Completion Date: March 2016
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Single arm observational study
To evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice
Device: Coronary stenting
The PROMUS™ Element™ Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 16 mm, 20 mm, 24 mm, 28 mm, 32 mm, 38mm) with a reference vessel diameter of 2.25 mm - 4.0 mm.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients who are candidates for Coronary artery stenting, signed the Informed Consent Form and are eligible to receive a PROMUS™ Element™ stent will be evaluated for enrollment in this study.

Criteria

Inclusion Criteria:

  • According to Instructions For Use

Exclusion Criteria:

  • Contraindications according to Instructions for Use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148329

  Show 41 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Pharmaceutical Research Associates, Inc.
Medidata Solutions
Investigators
Principal Investigator: Martyn R Thomas, MD PhD Guy's and St. Thomas NHS Foundation Trust, UK
Study Director: Monika Hanisch, PhD Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01148329     History of Changes
Other Study ID Numbers: S2057
Study First Received: June 21, 2010
Last Updated: August 9, 2013
Health Authority: Austria: Ethikkommission
Belgium: Ethics Committee
Denmark: Danish Dataprotection Agency
France: Institutional Ethical Committee
Germany: Ethics Commission
Hungary: Institutional Ethics Committee
Ireland: Medical Ethics Research Committee
Italy: Ethics Committee
Netherlands: Independent Ethics Committee
Poland: Ethics Committee
Spain: Ethics Committee
Sweden: Regional Ethical Review Board
United Kingdom: Research Ethics Committee

Keywords provided by Boston Scientific Corporation:
Coronary stenting
Drug-eluting stent
Post-market surveillance study
Promus Element stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 01, 2014