The NOrdic-Baltic Randomized Registry Study for Evaluation of PCI in Chronic Total Coronary Occlusion

Heart Failure Clinical Trial

— NOBLE-CTO  

Official title:

The NOrdic-Baltic Randomized Registry Study for Long-term Clinical Evaluation of Adjunction of PCI to Optimal Medical Therapy in Chronic Total Coronary Occlusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03392415
• Other study ID #: N-20170063
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 1, 2030

Study information

• Verified date: February 2023
• Source: Aalborg University Hospital
• Contact: Martin K Christensen, MD
• Phone: +45 9766 4454
• Email: m.kirk[@]rn.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized registry for the study of CTO PCI as adjunction to optimal medical therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: July 1, 2030
• Est. primary completion date: July 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =1 CTO lesion amenable to PCI.
• Stable and stabilized coronary artery disease
• Symptoms (angina pectoris or shortness of breath) and/or signs of reversible perfusion defect by SPECT, PET or MR and/or angiographic/echocardiographic indication of reversible ischemia.
• CTO lesion in a major coronary vessel supplying a significant myocardial territory (vessel diameter usually =3mm).

Exclusion Criteria:

• Expected survival <1 year.
• Renal failure on dialysis.
• Stable non-CTO lesions treated within one month.
• Declined informed consent.
• Regarding CMR: allergy to contrast medium, severe obesity, claustrophobia and certain metallic implants

Related Conditions & MeSH terms

• Angina Pectoris
• Chronic Total Occlusion of Coronary Artery
• Coronary Occlusion
• Heart Failure

Intervention

Procedure:
• CTO PCI
attempted percutaneous coronary intervention of the chronic total coronary occlusion

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Leif Thuesen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Socio-economic	Socio-economic consequenses of CTO PCI. Treatment cost compared to coronary bypass surgery	1 year
Primary	All-cause mortality	All-cause mortality after inclusion of 2000 patients	a minimal follow-up of 6 months
Primary	Quality of life assessment	Quality of life assessment by 12-Item Short Form Survey Instrument (SF-12v2)	6 months.
Secondary	MR perfusion	Reduction of inducible myocardial perfusion defect evaluated, improvement of left ventricular function and correlation of angina and perfusion defect	6 months
Secondary	Echocardiography	evaluation of systolic and diastolic left ventricular function compared to index echocardiography before CTO PCI.	6 months