2nd International Survey on Interventional Strategies

NCT ID: NCT04001452

Last Updated: 2019-06-28

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

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-01-31

Brief Summary

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The study aims to evaluate the decision-making pathways of interventional cardiologists, when assessing patients, presented with stable coronary artery disease.

Detailed Description

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2nd International Survey on Interventional Strategies is a web-based platform.

The survey contains specific questions and dedicated case presentations on two major topics.

The first part queries the characteristics of the participants, including overall experience in interventional cardiology, annual volume of percutaneous coronary intervention (PCI), and duration of experience with quantitative coronary angiography (QCA), intravascular ultrasound (IVUS),optical coherence tomography (OCT), fractional flow reserve (FFR) and non-hyperaemic pressure ratios (NHPR). The survey uses here predefined categories and single-choice questions.

The second part investigates personal strategies for evaluating angiographically intermediate stenoses in the catheterization laboratory. Here, participants are asked to evaluate 5 complete coronary angiograms. All cases are characterised as stable angina without relevant changes on resting ECG. No information about non-invasive testing is known or provided.

Here participants are asked to (1) localise all relevant stenoses by indicating the involved segment; (2) define percent diameter stenosis (%DS) by visual estimate; and (3) determine the significance of the stenosis of interest. In cases of angiographic uncertainty, the preferred diagnostic tool is asked to be selected from the arsenal available in the catheterisation laboratory, namely QCA, IVUS, OCT, FFR or NHPR. Participants are asked to make their decisions assuming ideal world conditions, without considering any financial restrictions or local regulations, but only after the best clinical practice achievable in this virtual catheterisation laboratory.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Level of experience in interventional cardiology

Total cohort will be grouped according to experience in interventional cardiology, as defined by a single choice questionnaire:

Yearly personal PCI volume Less than 75 / Between 75 and 150 / Between 151 and 250 / More than 250

No interventions assigned to this group

Level of experience with intravascular ultrasound

Total cohort will be grouped according to experience with intravascular ultrasound, as defined by a single choice questionnaire:

General: No experience / Less than 1 year / Between 1 and 3 years / Between 3 and 5 years / More than 5 years

Yearly: None / Less than 15 / Between 15 and 50 / More than 50

No interventions assigned to this group

Level of experience with optical coherence tomography

Total cohort will be grouped according to experience with optical coherence tomography, as defined by a single choice questionnaire:

General: No experience / Less than 1 year / Between 1 and 3 years / Between 3 and 5 years / More than 5 years

Yearly: None / Less than 15 / Between 15 and 50 / More than 50

No interventions assigned to this group

Level of experience with fractional flow reserve

Total cohort will be grouped according to experience with fractional flow reserve, as defined by a single choice questionnaire:

General: No experience / Less than 1 year / Between 1 and 3 years / Between 3 and 5 years / More than 5 years

Yearly: None / Less than 50 / Between 50 and 150 / Between 151 and 250 / More than 250

No interventions assigned to this group

Level of experience with non-hyperaemic pressure ratios

Total cohort will be grouped according to experience with non-hyperaemic pressure ratios, as defined by a single choice questionnaire:

General: No experience / Less than 1 year / Between 1 and 3 years / Between 3 and 5 years / More than 5 years

Yearly: None / Less than 50 / Between 50 and 150 / Between 151 and 250 / More than 250

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Interventional cardiologists
* Interventional cardiologists in training
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Gabor Toth-Gayor

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Gabor G Toth, MD, PhD

Role: CONTACT

Phone: 0043 316 385 12544

Email: [email protected]

Emanuele Barbato, MD, PhD

Role: CONTACT

Email: [email protected]

References

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Toth GG, Toth B, Johnson NP, De Vroey F, Di Serafino L, Pyxaras S, Rusinaru D, Di Gioia G, Pellicano M, Barbato E, Van Mieghem C, Heyndrickx GR, De Bruyne B, Wijns W. Revascularization decisions in patients with stable angina and intermediate lesions: results of the international survey on interventional strategy. Circ Cardiovasc Interv. 2014 Dec;7(6):751-9. doi: 10.1161/CIRCINTERVENTIONS.114.001608. Epub 2014 Oct 21.

Reference Type BACKGROUND
PMID: 25336468 (View on PubMed)

G Toth G, Johnson NP, Wijns W, Toth B, Achim A, Fournier S, Barbato E. Revascularization decisions in patients with chronic coronary syndromes: Results of the second International Survey on Interventional Strategy (ISIS-2). Int J Cardiol. 2021 Aug 1;336:38-44. doi: 10.1016/j.ijcard.2021.05.005. Epub 2021 May 7.

Reference Type DERIVED
PMID: 33971185 (View on PubMed)

Other Identifiers

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ISIS 2

Identifier Type: -

Identifier Source: org_study_id