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Clinical Trials/NL-OMON51591
NL-OMON51591
Completed
Phase 4

Comprehensive Medical and Invasive Treatment strategy for patients with significant Left Anterior Descending artery disease - COMMIT-LAD

Zuyderland Medisch Centrum0 sites460 target enrollmentStarted: TBDLast updated:

Overview

Phase
Phase 4
Status
Completed
Sponsor
Zuyderland Medisch Centrum
Enrollment
460

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • Stable coronary artery disease OR
  • Hemodynamically stable patients with a Non\-STE Acute Coronary Syndrome AND
  • Hemodynamically significant LAD disease, as assessed by fractional flow reserve
  • (FFR, \<\= 0\.80\) measurements; OR \>90% lesion; OR non\-invasive evidence of ischemia.
  • Eligibility for complete revascularization (defined as a British Cardiovascular
  • Intervention Society \[BCIS] revascularisation index \>0\.8\). Please be aware that
  • in the case of a diffusely diseased LAD and randomisation for the percutaneous
  • arm, optimal medical therapy is seen as LAD\-revascularization.
  • The local Heart Team must conclude that:
  • The LAD, irrespective of focal or diffuse disease, is suitable for both

Exclusion Criteria

  • Previous CABG
  • Any target lesion with in\-stent restenosis within 1 year
  • Significant Left Main involvement
  • Significant valvular heart disease
  • Prior anterior myocardial infarction with clear evidence of residual akinesia
  • and/or dyskinesia
  • Extremely calcified or tortuous vessels precluding LAD FFR measurement or OCT
  • of the LAD.
  • Planned major surgery within the next 12 months
  • Extra\-cardiac illness that is expected to limit survival to less than 1 years

Investigators

Sponsor
Zuyderland Medisch Centrum

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