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

NCT ID: NCT03392415

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2030-07-01

Brief Summary

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

Detailed Description

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Conditions

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Chronic Total Occlusion of Coronary Artery Heart Failure Angina Pectoris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized registry with option of crossover after 6months
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Initial conservative treatment

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

Group Type ACTIVE_COMPARATOR

CTO PCI

Intervention Type PROCEDURE

attempted percutaneous coronary intervention of the chronic total coronary occlusion

initial interventional treatment

CTO PCI attempt as initial strategy with medical optimization simultaneously

Group Type EXPERIMENTAL

CTO PCI

Intervention Type PROCEDURE

attempted percutaneous coronary intervention of the chronic total coronary occlusion

Interventions

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CTO PCI

attempted percutaneous coronary intervention of the chronic total coronary occlusion

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leif Thuesen

OTHER

Sponsor Role lead

Responsible Party

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Leif Thuesen

Senior consultant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Søren Pihlkjær Hjortshøj, MD

Role: STUDY_CHAIR

Aalborg University Hospital

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Martin K Christensen, MD

Role: CONTACT

+45 9766 4454

Leif Thuesen, MD

Role: CONTACT

+45 9766 4465

Facility Contacts

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Leif Thuesen, MD

Role: primary

+4522328264

References

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Christensen MK, Eftekhari A, Raungaard B, Steigen TK, Kumsaars I, Riahi S, Sogaard P, Thuesen L. Impact of Percutaneous Intervention Compared to Pharmaceutical Therapy on Complex Arrhythmias in Patients With Chronic Total Coronary Occlusion. Rationale and Design of the CTO-ARRHYTHMIA Study. Cardiovasc Revasc Med. 2023 Sep;54:69-72. doi: 10.1016/j.carrev.2023.04.001. Epub 2023 Apr 10.

Reference Type DERIVED
PMID: 37117085 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34238552 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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N-20170063

Identifier Type: -

Identifier Source: org_study_id

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