NCT02150876

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

3 months

First QC Date

May 27, 2014

Last Update Submit

December 1, 2015

Conditions

Coronary Artery Disease

Keywords

DESSDFMACESYNERGY

Outcome Measures

Primary Outcomes (1)

  • MACE

    12-month device-oriented MACE (dMACE) as defined by ARC (cardiac death, MI and TLR).

    at 12 month follow up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patient treated by everolimus-eluting SYNERGY® stent

You may not qualify if:

  • \. Patient or legal guardian won't give consent to use collected data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Freiburg

Fribourg, Canton of Fribourg, 1700, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Stéphane P Cook, MD

    University of Freiburg

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 27, 2014

First Posted

May 30, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

CH(1)