NCT02421016

Brief Summary

The bioresorbable polymer SYNERGY EES exhibits a favourable vascular healing profile in patients undergoing coronary intervention for de novo lesions. Specifically, the SYNERGY EES is superior to the ABSORB bioresorbable vascular scaffold in terms of antirestenotic efficacy as assessed by angiography at 6-8 months.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 9, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 2, 2015

Status Verified

April 1, 2015

Enrollment Period

1.6 years

First QC Date

April 9, 2015

Last Update Submit

June 1, 2015

Conditions

Coronary Stenosis

Keywords

De novo stenosisbioresorbable polymer coatingbioresorbable polymer backbone

Outcome Measures

Primary Outcomes (1)

  • Percentage diameter stenosis (in-stent) by quantitative coronary angiography analysis

    at 6-8 months

Secondary Outcomes (4)

  • Composite of cardiac death/target vessel-myocardial infarction (MI)/ target lesion revascularization (TLR) (Device-oriented composite endpoint)

    at 12 months

  • Composite of death/any MI/all revascularization (Patient-oriented composite endpoint)

    at 12 months

  • Composite of cardiovascular death or MI

    at 12 months

  • Stent Thrombosis

    at 12 months

Study Arms (2)

SYNERGY EES

EXPERIMENTAL

Bioresorbable polymer everolimus-eluting stent

Device: SYNERGY EES

ABSORB [BVS]

ACTIVE COMPARATOR

Everolimus-eluting bioresorbable backbone stent

Device: ABSORB [BVS]

Interventions

SYNERGY EESDEVICE

Bioresorbable polymer everolimus-eluting stent

SYNERGY EES
ABSORB [BVS]DEVICE

Everolimus-eluting bioresorbable backbone stent

ABSORB [BVS]

Eligibility Criteria

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

You may qualify if:

  • Patients 18 years or older with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary vessels (max. 2 lesions in 2 separate vessels)
  • Reference diameter ≥2.5 mm and ≤3.9 mm
  • Lesion length \<28 mm
  • Written, informed consent by the patient for participation in the study

You may not qualify if:

  • Cardiogenic shock
  • Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
  • Target lesion located in left main trunk or bypass graft
  • Severe calcification of the lesion
  • Target lesion contains a side branch (diameter ≥2mm) or a bifurcation or is located 2 mm away from a bifurcation
  • Ostial lesions
  • Severe vessel tortuosity
  • Renal insufficiency (most recent serum creatinine within the last 72h prior to randomization \> 2 mg/dl or 177 µmol/l)
  • Malignancies or other co-morbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance
  • Pregnancy, present (positive pregnancy test), suspected or planned, breast feeding
  • Contraindications or allergy to platinum, chromium, everolimus or the inability to take antiplatelet therapy for at least 6 months after stenting; known allergy to PLLA, PDLLA or PLGA polymer
  • Previous enrollment in this trial
  • Patient's inability to fully cooperate with the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum München

Munich, Bavaria, 80636, Germany

RECRUITING

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Robert Byrne, MB BCh PhD

    Deutsches Herzzentrum München

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Byrne, MB BCh PhD

CONTACT

+49 89 1218byrne@dhm.mhn.de

Salvatore Cassese, MD

CONTACT

+49 89 1218Cassese@dhm.mhn.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2015

First Posted

April 20, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2016

Study Completion

April 1, 2017

Last Updated

June 2, 2015

Record last verified: 2015-04

Locations

DE(1)