NCT02546557

Brief Summary

The study is a voluntary study, initiated by B. Braun to collect clinical data for Optilene® suture concerning its key indication.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
4 countries

4 active sites

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

First Submitted

Initial submission to the registry

August 11, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 10, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

August 11, 2015

Last Update Submit

January 21, 2019

Conditions

Coronary Heart DiseaseMulti Vessel Coronary Artery Disease

Keywords

CABGCoronary Artery Bypass Grafting

Outcome Measures

Primary Outcomes (1)

  • postoperative CABG adverse events in hospital

    Incidence of individual postoperative CABG adverse events in hospital. Postoperative CABG adverse events are defined as the sum of the frequency of myocardial infarction, stroke, mortality, renal failure and gastrointestinal bleeding.

    day of discharge (average 7 to 10 days)

Secondary Outcomes (7)

  • Incidence of myocardial infarction (MI)

    until day of discharge (average 7 to 10 days), 30 days and 3 months postop

  • Incidence of stroke

    until day of discharge (average 7 to 10 days), 30 days and 3 months postop

  • Mortality

    until day of discharge (average 7 to 10 days), 30 days and 3 months postop

  • Gastrointestinal bleeding

    until day of discharge (average 7 to 10 days)

  • Incidence of renal failure

    until day of discharge (average 7 to 10 days)

  • +2 more secondary outcomes

Other Outcomes (4)

  • Repeat Revascularization

    until 1 and 3 months postop

  • Handling of the suture material

    at time of surgery

  • Length of the postoperative hospital stay

    Until discharge (average 7 to 10 days)

  • +1 more other outcomes

Study Arms (1)

OPTICABG

Patients undergoing a coronary artery bypass graft surgery for the repair of a multi-vessel disease or left main-coronary disease.

Procedure: Coronary Artery Bypass Graft surgery

Interventions

Coronary Artery Bypass Graft surgeryPROCEDURE
OPTICABG

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients

You may qualify if:

  • Patients undergoing an elective primary coronary artery bypass graft surgery (CABG).
  • On pump or off pump CABG surgery
  • Age ≥25 years
  • Written informed consent

You may not qualify if:

  • Emergency surgery
  • Insulin dependent Diabetes Mellitus
  • Acute myocardial infarction with Creatinine Kinase-MB level \> 10% of CK and /or ECG signs
  • Known immunodeficiency or immunosuppression
  • Other combined aortic valve intervention except cardiac valve or mitral valve surgery
  • Participation or planned participation in another cardiovascular study before study follow-up is completed.
  • Inability to give informed consent due to mental condition, mental retardation, or language barrier.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Robert Bosch KH Stuttgart

Stuttgart, 70376, Germany

Location

Sacco Hospital

Milan, 20157, Italy

Location

Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Hospital de la Santa Creu I Sant Pau

Barcelona, 08026, Spain

Location

Related Publications (2)

  • Hawkes AL, Nowak M, Bidstrup B, Speare R. Outcomes of coronary artery bypass graft surgery. Vasc Health Risk Manag. 2006;2(4):477-84. doi: 10.2147/vhrm.2006.2.4.477.

    PMID: 17323602BACKGROUND

  • Ursulescu A, Baumann P, Ferrer MT, Contino M, Romagnoni C, Antona C, Padro Fernandez JM. Optilene, a new non-absorbable monofilament is safe and effective for CABG anastomosis. OPTICABG - A prospective international, multi-centric, cohort study. Ann Med Surg (Lond). 2018 Sep 15;35:13-19. doi: 10.1016/j.amsu.2018.09.005. eCollection 2018 Nov.

    PMID: 30258627RESULT

MeSH Terms

Conditions

Coronary Disease

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Joseph M Padró, Prof. Dr.

    Hospitla de la Santa Creu I Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2015

First Posted

September 11, 2015

Study Start

November 10, 2015

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations

PT(1)DE(1)ES(1)IT(1)