NCT02919943

Brief Summary

To define and evaluate the impact of angiographic coregistered OCT on physicians decision-making through prospective data collection in PCI procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

September 27, 2016

Last Update Submit

May 14, 2017

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • The primary study objective is the change in PCI strategy after pre-procedural ACR as compared to OCT imaging alone

    20 months

Secondary Outcomes (5)

  • Major adverse cardiac event (MACE)-rate (death, myocardial infarction, Re-angiography, Re-PCI and renal failure requiring dialysis), after recruitment.

    30 days, 6 months, and 12 months.

  • Change in PCI strategy after pre-procedural OCT imaging in comparison to conventional angiography alone.

    20 months

  • Longitudinal geographical miss (GM) with uncovered residual parts of "target lesion" at the proximal or distal reference segment of the stent. Detected by comparison between pre-PCI OCT with post-PCI OCT.

    20 months

  • Rate of side branch occlusions (%).

    20 months

  • Strategy changes based on post-procedural OCT and ACR Imaging.

    20 months

Interventions

Percutaneous Coronary InterventionPROCEDURE

OCT-guided Percutaneous Coronary Intervention.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elective or ad hoc PCI, stable Angina, acute coronary syndrome

You may qualify if:

  • Age ≥ 18 years.
  • Patient provides signed written informed consent before any study-specific procedure.
  • Patients suffer from coronary artery disease (CAD) including at least one angiographically significant (\>70% visual estimation) stenosis present in a native coronary artery with planned PCI.

You may not qualify if:

  • Subjects with emergent PCI or in cardiogenic shock.
  • Subjects with target left main (LM) lesion, with restenosis or stent thrombosis in the target vessel or with aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
  • Extreme angulation (\> 90°) or excessive tortuosity (\> two 45° angles) proximal to or within the target lesion.
  • Known renal insufficiency (examples being but not limited to estimated glomerular Filtration rate (eGFR) \< 50 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL or on dialysis).
  • Any other medical condition that in the opinion of the investigator will interfere with patients safety or study results.
  • Currently participating in another clinical study that interferes with study results.
  • Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
  • Any condition that precludes the subject from undergoing PCI, for example subjects with heparin induced thrombocytopenia, or contrast allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • David M Leistner, PD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD M.D.

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 30, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

May 16, 2017

Record last verified: 2017-05

Locations

DE(1)