Nordic-Baltic Coronary Revascularization Study in Patients With Proximal Left Descending Coronary Artery (LAD) Lesion.

NCT03538886 | Terminated

• 1 other identifier: NOBLE-LAD_Protocol version 3
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The Nordic-Baltic Heart Team Initiative for improved long-term coronary artery revascularization outcome compares quality of life and survival after coronary bypass grafting (CABG) vs. percutaneous coronary intervention (PCI) in patients with 1-vessel disease and proximal stenosis of the anterior descending artery (LAD/in patients with isolated proximal left descending coronary artery (LAD) lesion

Conditions

Coronary Artery Disease

Keywords

Coronary revascularization

Outcome Measures

Primary Outcomes (3)

• All-cause mortality

  Death of any cause

  10 years

• Quality of life

  By SF 12 and Seatle Angina Questionaire

  1 year

• MACCE

  Major cardiac and cerebral adverse events (myocardial infarction, stroke, revascularization, death)

  1 year

Secondary Outcomes (8)

• All-cause death

  1, 2, 3, 5 and 10 years

• Cardiac death

  1, 2, 3, 5 and 10 years

• Spontaneous myocardial infarction

  1, 2, 3, 5 and 10 years

• Procedure related myocardial infarction

  1, 2, 3, 5 and 10 years

• Major stroke, minor stroke and al stroke

  1, 2, 3, 5 and 10 years

Study Arms (2)

Percutaneous coronary intervention (PCI)

ACTIVE COMPARATOR

Currently, percutaneous coronary intervention (PCI) using balloon and drug eluting stents is the treatment of choice for treatment of a proximal LAD lesion.

Procedure: Percutaneous coronary intervention (PCI)

Coronary artery bypass grafting (CABG)

EXPERIMENTAL

Coronary artery bypass grafting is a well established treatment with documented excellent long-term results for the treatment of proximal LAD lesion.

Procedure: Coronary artery bypass grafting (CABG)

Interventions

Coronary artery bypass grafting (CABG) PROCEDURE

Revascularization of LAD lesion by CABG

Coronary artery bypass grafting (CABG)

Percutaneous coronary intervention (PCI) PROCEDURE

Revascularization of LAD lesion by PCI

Percutaneous coronary intervention (PCI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heart Team decision on treatment
• VD patients with stable coronary artery disease or stabilized unstable angina pectoris/NSTEMI or silent ischemia Proximal LAD (pLAD) stenosis (\>90% by visual assessment or FFR \<80% The lesion may be treated by both PCI and surgery

You may not qualify if:

• ST-elevation myocardial infarction within 24 hours. Expected survival \<1 year, because of high age or severe cardiac or non-cardiac disease.
• Significant LM disease. Earlier CABG. PCI within 3 months. Significant valvular heart disease. Renal failure on dialysis Earlier disabling stroke Relative or absolute contraindication to dual antiplatelet therapy. Allergy relevant to the study treatments. Age \< 18 years. Study required information and consent suboptimal or impossible.

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Oulu University Hospital: collaborator
• Region Örebro County: collaborator
• Pauls Stradins Clinical University Hospital: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Artery Bypass; Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures; Endovascular Procedures; Minimally Invasive Surgical Procedures

Study Officials

• Leif Thuesen, MD

  Department of Cardiology, Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

• Jan Jesper Andreasen, Prof

  Department of Cardiothoracic Surgery, Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

• Peter Sogaard, Prof

  Department of Cardiology, aaalborg University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical outcomes will be assessed by an independent event committee with no knowledge of treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior interventional cardiologist

Model Details: 1:1 randomized clinical trial

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: June 1, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol and statistical analysis plan available by now.
• Access Criteria: At clinicaltrial.gov

Locations

DK (1)