Procedural Advantages of a Novel Drug-Eluting Coronary Stent

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881216
• Other study ID #: Synergy Stent
• Status: Completed
• Phase: N/A
• First received: August 15, 2016
• Last updated: August 25, 2016
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 814
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• CAD for PCI, consecutive patients

Exclusion Criteria:

• Age under 18

• Bare Metal Stents or Scaffolds

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Synergy Stent
Patients with narrowed coronary artery disease qualifying for PCI were treated with Synergy stent implantation.
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes