SYNERGY™ & SYNERGY MEGATRON™

Everolimus-Eluting Platinum Chromium Coronary Stent System

EVOLVE

COMPLETE
First Human Use Trial.
291 patients.
PROMUS Element vs. SYNERGY vs. SYNERGY Half-Dose (1:1:1).
Primary Endpoint: 6 month Late Loss + Composite Safety @ 30 days

EVOLVE II RCT

COMPLETE
Global IDE Trial.
1684 patients, 125 sites, 16 countries.
PROMUS Element Plus vs. SYNERGY (1:1) single-blind trial.
Primary Endpoint: 12 month TLF

EVOLVE II QCA

COMPLETE
Quantitative Angiography.
100 Patient Registry, 12 sites (Australia, Japan, New Zealand, Singapore).
Primary Endpoint: 9 month in-stent Late Loss

EVOLVE China

COMPLETE
China regulatory approval trial (SFDA).
400 patients, 15 sites.
PROMUS Element Plus vs. SYNERGY (1:1)
Primary Endpoint: 9 month Late Loss

EVOLVE China

ENROLLMENT COMPLETE
3 Month DAPT.
Prospective, ~2000 patients, ~120 global sites.
Co-primary Endpoints: (1) Death/MI and (2) ARC definite/probable ST
 

SYNERGY™ Stent Reported Low Event Rates in a Leading Complex PCI Center in Belfast, Ireland

The SYNERGY Stent demonstrated very low TLF and 0% ST in real world analysis.
Clinical Characteristics*
  SYNERGY Stent
N patients

185

Class C Lesions

81.1%

Turned down for surgical revasc

23.8%

LM PCI

14.1%

Multi-vessel Disease

33%

CTO

33%

3 months DAPT

78%

Results at a mean follow-up of 664 days**
Results at a mean follow-up of 664 days
 

CONSISTENT CTO Trial 12-month Results

CONventional antegrade vs Sub-Intimal Synergy sTENTing in Chronic Total Occlusions

Trial Design:
Single-arm, 6 center study of 210 CTO patients evaluating primary end-point of TVF vs performance goal with the SYNERGY™ BP-DES.

Key Trial Details:1

  • 90.5% of patients had pre-PCI IVUS
  • 90% CTO success rate
  • Very complex and symptomatic patients
    • JCTO Score of 2.4
    • Mean stent length 85.6 mm
    • 21% diabetic patients
  • Significant QoL gains at 12-months following successful CTO PCI

Presenter conclusion:
SYNERGY BP-DES highly effective in CTO PCI

 
Optimal Healing

Optimal Healing

Advanced design for optimal healing

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Real-World

Real-World Studies

How design impacts economic value

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