Procedural Advantages of a Novel Drug-Eluting Coronary Stent

NCT ID: NCT02881216

Last Updated: 2016-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

814 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type OTHER

Currently common drug-eluting stent (DES)

Intervention Type DEVICE

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

Synergy Stent

Group of Patients with narrowed coronary artery disease, who were treated with Synergy stent implantation

Group Type OTHER

Synergy Stent

Intervention Type DEVICE

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

Interventions

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Synergy Stent

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

Intervention Type DEVICE

Currently common drug-eluting stent (DES)

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

Intervention Type DEVICE

Other Intervention Names

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Synergy Coronary Stent DES including Xience Prime, Resolute Integrity, Promus Element Plus.

Eligibility Criteria

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Inclusion Criteria

* CAD for PCI, consecutive patients

Exclusion Criteria

* Age under 18
* Bare Metal Stents or Scaffolds
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Haitham Abu Sharar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Synergy Stent

Identifier Type: -

Identifier Source: org_study_id

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