Procedural Advantages of a Novel Drug-Eluting Coronary Stent

August 25, 2016 updated by: Haitham Abu Sharar, University Hospital Heidelberg

Procedural Advantages of a Novel Drug-Eluting Coronary Stent With Ultra-Thin Struts and Bioabsorbable Abluminal Polymer Coating in an All-Comers Registry

This study sought to compare procedural performance of a new coronary stent generation, that is already available in Germany, with hitherto established current drug-eluting stents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

814

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • CAD for PCI, consecutive patients

Exclusion Criteria:

  • Age under 18
  • Bare Metal Stents or Scaffolds

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Common DES
Group of Patients with narrowed coronary artery disease, who were treated with an implantation of currently established drug-eluting stents (Xience Prime, Promus Element plus, Resolute Integrity).
Device: Currently common drug-eluting stent (DES)
Patients with narrowed coronary artery disease qualifying for PCI were treated with DES implantation (Xience Prime, Resolute Integrity, Promus Element Plus)
Other Names:
  • DES including Xience Prime, Resolute Integrity, Promus Element Plus.
Other: Synergy Stent
Group of Patients with narrowed coronary artery disease, who were treated with Synergy stent implantation
Device: Synergy Stent
Patients with narrowed coronary artery disease qualifying for PCI were treated with Synergy stent implantation.
Other Names:
  • Synergy Coronary Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital major cardiac adverse events
Time Frame: One week post-procedure
In-hospital major cardiac adverse events were collected up to one week after procedure throughout the in-patients stay
One week post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Estimate)

August 29, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Synergy Stent

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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