Coronary Artery DiseaseNCT02881216
Procedural Advantages of a Novel Drug-Eluting Coronary Stent
A study testing Synergy Stent and Currently common drug-eluting stent (DES) in people with Coronary Artery Disease, run by University Hospital Heidelberg.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Synergy Stent and Currently common drug-eluting stent (DES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 814 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CAD for PCI, consecutive patients
Who cannot join
- Age under 18
- Bare Metal Stents or Scaffolds
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Synergy Stent, Currently common drug-eluting stent (DES)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synergy StentDevice
Also called Synergy Coronary Stent
Patients with narrowed coronary artery disease qualifying for PCI were treated with Synergy stent implantation.
Currently common drug-eluting stent (DES)Device
Also called DES including Xience Prime, Resolute Integrity, Promus Element Plus.
Patients with narrowed coronary artery disease qualifying for PCI were treated with DES implantation (Xience Prime, Resolute Integrity, Promus Element Plus)
| Study group | Role | What they receive |
|---|---|---|
| Common DES | Other | 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). Receives: Device: Currently common drug-eluting stent (DES) |
| Synergy Stent | Other | Group of Patients with narrowed coronary artery disease, who were treated with Synergy stent implantation Receives: Device: Synergy Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital major cardiac adverse events
In-hospital major cardiac adverse events were collected up to one week after procedure throughout the in-patients stay
Measured: One week post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 814 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitham Abu Sharar, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881216
- Sponsor's protocol ID
- Synergy Stent
- Status last verified
- Aug 2016
- First submitted
- 15 Aug 2016
- Last updated
- 29 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedural Advantages of a Novel Drug-Eluting Coronary Stent With Ultra-Thin Struts and Bioabsorbable Abluminal Polymer Coating in an All-Comers Registry
- ClinicalTrials.gov ID
- NCT02881216
- Acronym / sponsor ID
- Synergy Stent
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 814 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common DES | Other | Device: Currently common drug-eluting stent (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). |
| Synergy Stent | Other | Device: Synergy StentGroup of Patients with narrowed coronary artery disease, who were treated with Synergy stent implantation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CAD for PCI, consecutive patients
Key exclusion criteria (2 listed)
- Age under 18
- Bare Metal Stents or Scaffolds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synergy StentAlso: Synergy Coronary StentPatients with narrowed coronary artery disease qualifying for PCI were treated with Synergy stent implantation. | Device | Synergy Stent |
| Currently common drug-eluting stent (DES)Also: DES including Xience Prime, Resolute Integrity, Promus Element Plus.Patients with narrowed coronary artery disease qualifying for PCI were treated with DES implantation (Xience Prime, Resolute Integrity, Promus Element Plus) | Device | Common DES |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Synergy Stent and Currently common drug-eluting stent (DES) in people with Coronary Artery Disease, run by University Hospital Heidelberg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital major cardiac adverse events (time frame: One week post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2016.