NCT02881216

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
814

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable coronary-artery-disease

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

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

11 months

First QC Date

August 15, 2016

Last Update Submit

August 25, 2016

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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

    One week post-procedure

Study Arms (2)

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).

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

Device: Synergy Stent

Interventions

Synergy StentDEVICE

Patients with narrowed coronary artery disease qualifying for PCI were treated with Synergy stent implantation.

Also known as: Synergy Coronary Stent
Synergy Stent
Currently common drug-eluting stent (DES)DEVICE

Patients with narrowed coronary artery disease qualifying for PCI were treated with DES implantation (Xience Prime, Resolute Integrity, Promus Element Plus)

Also known as: DES including Xience Prime, Resolute Integrity, Promus Element Plus.
Common DES

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CAD for PCI, consecutive patients

You may not qualify if:

  • Age under 18
  • Bare Metal Stents or Scaffolds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 26, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

August 29, 2016

Record last verified: 2016-08