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).
|
Patients with narrowed coronary artery disease qualifying for PCI were treated with DES implantation (Xience Prime, Resolute Integrity, Promus Element Plus)
Other Names:
|
|
Other: Synergy Stent
Group of Patients with narrowed coronary artery disease, who were treated with Synergy stent implantation
|
Patients with narrowed coronary artery disease qualifying for PCI were treated with Synergy stent implantation.
Other Names:
|
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
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.