CClinicalTrials.gg
Status unknownNCT04001452Updated Jun 28, 2019

2nd International Survey on Interventional Strategies

An observational study in Coronary Artery Disease, sponsored by Medical University of Graz. Status unknown. Per ClinicalTrials.gov, last updated 2019-06-28.

Sponsored by Medical University of Graz · Observational

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Sex
All
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Coronary Artery Disease
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 500 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants will be invited to join the survey via different online platforms and via social media.

Eligibility criteria

Inclusion criteria

  • Interventional cardiologists
  • Interventional cardiologists in training
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

  • 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

  • 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

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What researchers measure

Primary outcomes

  1. Need for using any additional diagnostic tool

    It will be assessed, how often participants express their desire to use one or other additional diagnostic tool to make a decision about lesion significance

    Time frame: One month

Secondary outcomes

  1. Need for using any additional diagnostic tool in different subgroups

    It will be assessed, how often the different subgroups of participants (i.e. by age, by interventional experience, by experience with different tools) express their desire to use one or other additional diagnostic tool to make a decision about lesion significance

    Time frame: One month

  2. Accuracy of visually estimated lesion severity

    Visually estimated diameter stenosis will be compared to quantitatively assessed diameter stenosis

    Time frame: One month

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 25336468 ↗
  • 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. PubMed 33971185 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04001452
Lead sponsor
Medical University of Graz
Collaborators
Abbott
Responsible party
Gabor Toth-Gayor (Principal Investigator, Medical University of Graz) — Principal investigator
First posted
Jun 28, 2019
Start date
Jul 1, 2019 (estimated)
Primary completion
Dec 31, 2019 (estimated)
Completion
Jan 31, 2020 (estimated)
Last update
Jun 28, 2019

Study contacts

Gabor G Toth, MD, PhD
Contact
gabor.g.toth@medunigraz.at
0043 316 385 12544
Emanuele Barbato, MD, PhD
Contact
emanuele.barbato@unina.it

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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