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

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

CTO PCI

About this trial

This is an interventional treatment trial for Chronic Total Occlusion of Coronary Artery focused on measuring chronic total occlusion, CTO, PCI, percutaneus coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Aalborg University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Initial conservative treatment

initial interventional treatment

Arm Description

Optimal medical therapy and option for crossover after 6 months or fulfillment of certain conditions

CTO PCI attempt as initial strategy with medical optimization simultaneously

Outcomes

Primary Outcome Measures

All-cause mortality

All-cause mortality after inclusion of 2000 patients

Quality of life assessment

Quality of life assessment by 12-Item Short Form Survey Instrument (SF-12v2)

Secondary Outcome Measures

MR perfusion

Reduction of inducible myocardial perfusion defect evaluated, improvement of left ventricular function and correlation of angina and perfusion defect

Echocardiography

evaluation of systolic and diastolic left ventricular function compared to index echocardiography before CTO PCI.

Full Information

NCT ID

NCT03392415

First Posted

November 20, 2017

Last Updated

February 10, 2023

Sponsor

Leif Thuesen

1. Study Identification

Unique Protocol Identification Number

NCT03392415

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

July 1, 2030 (Anticipated)

Study Completion Date

July 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Leif Thuesen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

chronic total occlusion, CTO, PCI, percutaneus coronary intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Randomized registry with option of crossover after 6months

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Initial conservative treatment

Arm Type

Active Comparator

Arm Description

Optimal medical therapy and option for crossover after 6 months or fulfillment of certain conditions

Arm Title

initial interventional treatment

Arm Type

Experimental

Arm Description

CTO PCI attempt as initial strategy with medical optimization simultaneously

Intervention Type

Procedure

Intervention Name(s)

CTO PCI

Intervention Description

attempted percutaneous coronary intervention of the chronic total coronary occlusion

Primary Outcome Measure Information:

Title

All-cause mortality

Description

All-cause mortality after inclusion of 2000 patients

Time Frame

a minimal follow-up of 6 months

Title

Quality of life assessment

Description

Quality of life assessment by 12-Item Short Form Survey Instrument (SF-12v2)

Time Frame

6 months.

Secondary Outcome Measure Information:

Title

MR perfusion

Description

Reduction of inducible myocardial perfusion defect evaluated, improvement of left ventricular function and correlation of angina and perfusion defect

Time Frame

6 months

Title

Echocardiography

Description

evaluation of systolic and diastolic left ventricular function compared to index echocardiography before CTO PCI.

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

Socio-economic

Description

Socio-economic consequenses of CTO PCI. Treatment cost compared to coronary bypass surgery

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Martin K Christensen, MD

Phone

+45 9766 4454

m.kirk@rn.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Leif Thuesen, MD

Phone

+45 9766 4465

leif.thuesen@rn.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Søren Pihlkjær Hjortshøj, MD

Organizational Affiliation

Aalborg University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Aalborg University Hospital

City

Aalborg

ZIP/Postal Code

9100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leif Thuesen, MD

Phone

+4522328264

leif.thuesen@rn.dk

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34238552

Citation

Rinfret S, Sandesara PB. Reducing Ischemia With CTO PCI: Good News, But Questions Remain. JACC Cardiovasc Interv. 2021 Jul 12;14(13):1419-1422. doi: 10.1016/j.jcin.2021.05.028. No abstract available.

Results Reference

derived

Learn more about this trial

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

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