Coronary Artery DiseaseNCT02150876
SWiss Evaluation of Bioabsorbable Polymer-coated Everolimus-eluting Coronary sTent
An observational study of Coronary Artery Disease, run by University of Freiburg at 1 site in Switzerland.
Trial summary
Bioresorbable polymer drug eluting stents (DES) are an indisputable improvement over first-generation DES with promising results on long-term adverse events. But the thicker polymer and/or strut may hinder its deliverability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 1,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2014to Sep 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients treated with SYNERGY stents at Bern and Fribourg university hospitals and La Tour Hospital in Geneva until June 30, 2014 will be retrospectively included in the study.
Who may be able to join
- 1.Patient treated by everolimus-eluting SYNERGY® stent
Who cannot join
- 1. Patient or legal guardian won't give consent to use collected data
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Freiburg
Fribourg, Canton of Fribourg, 1700
About this study
Official title: SWiss Evaluation of Bioabsorbable Polymer-coated Everolimus-eluting Coronary sTent The SWEET Registry
Bioresorbable polymer drug eluting stents (DES) are an indisputable improvement over first-generation DES with promising results on long-term adverse events. But the thicker polymer and/or strut may hinder its deliverability. Complex procedures challenge stent deliverability and stent delivery failure impacts clinical prognosis.
This registry aimed to assess the immediate performance of the third-generation Synergy everolimus-eluting stent (sEES) and its 12-month clinical follow-up in an all-comer population.
Read the detailed description
All consecutive patients treated with the SYNERGY stent at our institutions were prospectively included in the SWEET registry. Baseline and procedural characteristics were collected at index procedure. Clinical follow-up was performed at 1 month and 1 year by clinic visit or follow-up call. The study end point was a composite of cardiac death (CD), myocardial infarction (MI) and target lesion revascularization (TLR) at 1 year.
- Conditions
- Coronary Artery Disease
- Keywords
- DES, SDF, MACE, SYNERGY
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
12-month device-oriented MACE (dMACE) as defined by ARC (cardiac death, MI and TLR).
Measured: at 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionSep 2014
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stéphane Cook, Prof, University of Freiburg
- Investigators
- Stéphane P Cook, MD, Study chair, University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150876
- Sponsor's protocol ID
- The SWEET registry
- Status last verified
- Dec 2015
- First submitted
- 27 May 2014
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWiss Evaluation of Bioabsorbable Polymer-coated Everolimus-eluting Coronary sTent The SWEET Registry
- ClinicalTrials.gov ID
- NCT02150876
- Acronym / sponsor ID
- The SWEET registry
- Conditions
- Coronary Artery Disease
- Keywords
- DES, SDF, MACE, SYNERGY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of FreiburgUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 May 2014 (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.
Bioresorbable polymer drug eluting stents (DES) are an indisputable improvement over first-generation DES with promising results on long-term adverse events. But the thicker polymer and/or strut may hinder its deliverability. Complex procedures challenge stent deliverability and stent delivery failure impacts clinical prognosis.
This registry aimed to assess the immediate performance of the third-generation Synergy everolimus-eluting stent (sEES) and its 12-month clinical follow-up in an all-comer population.
Detailed description
All consecutive patients treated with the SYNERGY stent at our institutions were prospectively included in the SWEET registry. Baseline and procedural characteristics were collected at index procedure. Clinical follow-up was performed at 1 month and 1 year by clinic visit or follow-up call. The study end point was a composite of cardiac death (CD), myocardial infarction (MI) and target lesion revascularization (TLR) at 1 year.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients treated with SYNERGY stents at Bern and Fribourg university hospitals and La Tour Hospital in Geneva until June 30, 2014 will be retrospectively included in the study.
Key inclusion criteria (1 listed)
- 1.Patient treated by everolimus-eluting SYNERGY® stent
Key exclusion criteria (1 listed)
- 1. Patient or legal guardian won't give consent to use collected data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACE
Time frame: at 12 month follow up
12-month device-oriented MACE (dMACE) as defined by ARC (cardiac death, MI and TLR).
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 3 Dec 2015.
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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.
Stéphane P Cook, MD study chair
University of Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University of Freiburg at 1 site in Switzerland.
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 1 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 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
MACE (time frame: at 12 month follow up). 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 3 Dec 2015.