Coronary Artery DiseaseDEFINE-FLOWNCT02328820
Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses
A study testing Percutaneous coronary intervention (PCI) and Optimal medical therapy (OMT) in people with Coronary Artery Disease, run by The University of Texas Health Science Center, Houston at 12 sites in 6 countries.
Trial summary
This study evaluates the prognostic value and therapeutic potential of combined pressure and flow measurements when evaluating a coronary artery stenosis. Lesions with intact coronary flow reserve (CFR) despite a reduced fractional flow reserve (FFR) will receive optimal medical therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous coronary intervention (PCI) and Optimal medical therapy (OMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 12 sitesin 6 countries
- Study dates
- Oct 2014to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Eligible for PCI based on local practice standards during the current procedure (PCI cannot be staged).
- At least one epicardial stenosis of ≥50% diameter (by visual or quantitative assessment) and meeting the following criteria as determined by the operator based on either a prior or the current diagnostic angiogram:
- <100% diameter (not a chronic, total occlusion);
- in a native coronary artery (including side branches but excludes bypass grafts);
- of ≥2.5mm reference diameter (near the level of the stenosis);
- and supplies sufficiently viable myocardium (exclude regions of known, prior, transmural myocardial infarction).
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Anatomic exclusions:
- Prior CABG.
- Preferred treatment strategy for revascularization would be CABG based on local practice standards.
- Left main coronary artery disease requiring revascularization.
- Extremely tortuous or calcified coronary arteries precluding intracoronary physiologic measurements. Operators may also exclude subtotal or similar high-grade lesions, which in their judgment may be threatened by ComboWire placement.
- Known severe LV hypertrophy (septal wall thickness at echocardiography of >13 mm).
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- Clinical exclusions:
- Inability to receive intravenous adenosine (for example, severe reactive airway disease, marked hypotension, or high-grade AV block without pacemaker).
- Recent (within 3 weeks prior to cardiac catheterization) ST-segment elevation myocardial infarction (STEMI) in any arterial distribution (not specifically target lesion).
- Culprit lesions (based on clinical judgment of the operator) for either STEMI or non-STEMI cannot be included.
- Severe cardiomyopathy (LV ejection fraction <30%).
- Planned need for cardiac surgery (for example, valve surgery, treatment of aortic aneurysm, or septal myomectomy).
- General exclusions:
- A life expectancy of less than 2 years.
- Inability to sign an informed consent, due to any mental condition that renders the subject unable to understand the nature, scope, and possible consequences of the trial or due to mental retardation or language barrier.
- Potential for non-compliance towards the requirements for follow-up visits.
- Participation or planned participation in another cardiovascular clinical trial before completing the 24 month follow-up.
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
Japan4 sites
Gifu Heart Center
Gifu
Toda Central General Hospital
Toda
Tokyo Medical University
Tokyo
Tsuchiura Kyodo
Tsuchiura
Netherlands4 sites
Amsterdam UMC - location AMC
Amsterdam
Amsterdam UMC - location VUmc
Amsterdam
Tergooi Hospital
Blaricum
Amphia Hospital
Breda
About this study
Official title: DEFINE-FLOW (Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect - Combined Pressure and Doppler FLOW Velocity Measurements)
This study evaluates the prognostic value and therapeutic potential of combined pressure and flow measurements when evaluating a coronary artery stenosis. Lesions with intact coronary flow reserve (CFR) despite a reduced fractional flow reserve (FFR) will receive optimal medical therapy. Only lesions with a simultaneous reduction in both CFR and FFR will be treated with percutaneous coronary intervention (PCI).
Read the detailed description
Pressure and flow represent the two physiologic variables that can be measured directly inside a coronary artery. Already pressure measurements have proven their clinical value in the form of fractional flow reserve (FFR). However, myocardial function can remain intact with sufficient flow, even at a low perfusion pressure. Therefore, combined pressure and flow measurements provide a more complete description of physiologic stenosis severity as a guide to medical treatment versus revascularization. Based on existing work relating the most common flow measurement, coronary flow reserve (CFR), to FFR and linking both variables with subsequent prognosis, we hypothesize that lesions with an intact CFR>=2.0 can be reasonably treated with medical therapy despite a reduced FFR<=0.8.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous coronary intervention (PCI), Optimal medical therapy (OMT)
- Keywords
- Fractional Flow Reserve, Myocardial, Coronary Flow Reserve
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention (PCI)Other
For lesions with both FFR<=0.8 and CFR<2.0
Optimal medical therapy (OMT)Other
For lesions with FFR>0.8 or CFR>=2.0 or both
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | All lesions undergo simultaneous assessment with a combined pressure and flow sensor Receives: Other: Percutaneous coronary intervention (PCI); Other: Optimal medical therapy (OMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
All-cause death, non-fatal myocardial infarction, urgent and elective revascularization
Measured: 24 months
Secondary outcomes (1)
Angina (Canadian Cardiovascular Society (CCS) anginal class (or freedom from angina)
Canadian Cardiovascular Society (CCS) anginal class (or freedom from angina)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2019
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Volcano Corporation
- Responsible party
- Principal investigator, Nils Johnson, The University of Texas Health Science Center, Houston
- Investigators
- Nils Johnson, MD, Principal investigator, University of Texas Medical School at HoustonJan J Piek, MD, PhD, Study director, Academic Medical Center (AMC), Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328820
- Sponsor's protocol ID
- HSC-MS-14-0442
- Other IDs
- NL48375.018.14
- Acronym
- DEFINE-FLOW
- Status last verified
- Apr 2021
- First submitted
- 18 Dec 2014
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johnson NP, Kirkeeide RL, Gould KL. Is discordance of coronary flow reserve and fractional flow reserve due to methodology or clinically relevant coronary pathophysiology? JACC Cardiovasc Imaging. 2012 Feb;5(2):193-202. doi: 10.1016/j.jcmg.2011.09.020.
PubMed 22340827van de Hoef TP, van Lavieren MA, Damman P, Delewi R, Piek MA, Chamuleau SA, Voskuil M, Henriques JP, Koch KT, de Winter RJ, Spaan JA, Siebes M, Tijssen JG, Meuwissen M, Piek JJ. Physiological basis and long-term clinical outcome of discordance between fractional flow reserve and coronary flow velocity reserve in coronary stenoses of intermediate severity. Circ Cardiovasc Interv. 2014 Jun;7(3):301-11. doi: 10.1161/CIRCINTERVENTIONS.113.001049. Epub 2014 Apr 29.
PubMed 24782198Tas A, Alan Y, Tas IK, Aydin OE, Atay Z, Yilmaz S, Ozcan A, van de Hoef TP, Umman S, Piek Md JJ, Sezer M. Coronary Microvascular Dysfunction Alters the Pulsatile Behavior of the Resting Coronary Blood Flow. Microcirculation. 2025 Aug;32(6):e70021. doi: 10.1111/micc.70021.
PubMed 40831095Tas A, Alan Y, Kara Tas I, Umman S, Parker KH, van de Hoef TP, Sezer M, Piek JJ. The impact of high microvascular resistance on coronary wave energetics depends on coronary microvascular functionality. Eur Heart J Open. 2025 May 5;5(3):oeaf050. doi: 10.1093/ehjopen/oeaf050. eCollection 2025 May.
PubMed 40417173Tas A, Alan Y, Muftuogullari A, Haj Mohammad AIM, Umman S, Parker KH, Sezer M. Coronary microvascular dysfunction and autoregulatory capacity interfere with resting Dicrotic notch morphology. Microvasc Res. 2025 Jan;157:104750. doi: 10.1016/j.mvr.2024.104750. Epub 2024 Sep 30.
PubMed 39357645Achim A, Johnson NP, Liblik K, Burckhardt A, Krivoshei L, Leibundgut G. Coronary steal: how many thieves are out there? Eur Heart J. 2023 Aug 7;44(30):2805-2814. doi: 10.1093/eurheartj/ehad327.
PubMed 37264699van de Hoef TP, Stegehuis VE, Madera-Cambero MI, van Royen N, van der Hoeven NW, de Waard GA, Meuwissen M, Christiansen EH, Eftekhari A, Niccoli G, Lockie T, Matsuo H, Nakayama M, Kakuta T, Tanaka N, Casadonte L, Spaan JAE, Siebes M, Tijssen JGP, Escaned J, Piek JJ. Impact of core laboratory assessment on treatment decisions and clinical outcomes using combined fractional flow reserve and coronary flow reserve measurements - DEFINE-FLOW core laboratory sub-study. Int J Cardiol. 2023 Apr 15;377:9-16. doi: 10.1016/j.ijcard.2023.01.009. Epub 2023 Jan 11.
PubMed 36640965Eftekhari A, Westra J, Stegehuis V, Holm NR, van de Hoef TP, Kirkeeide RL, Piek JJ, Lance Gould K, Johnson NP, Christiansen EH. Prognostic value of microvascular resistance and its association to fractional flow reserve: a DEFINE-FLOW substudy. Open Heart. 2022 Apr;9(1):e001981. doi: 10.1136/openhrt-2022-001981.
PubMed 35410913Johnson NP, Collet C. Can FFR After Stenting Help Reduce Target Vessel Failure? JACC Cardiovasc Interv. 2021 Sep 13;14(17):1901-1903. doi: 10.1016/j.jcin.2021.08.001. No abstract available.
PubMed 34503740Murai T, Stegehuis VE, van de Hoef TP, Wijntjens GWM, Hoshino M, Kanaji Y, Sugiyama T, Hamaya R, Nijjer SS, de Waard GA, Echavarria-Pinto M, Knaapen P, Meuwissen M, Davies JE, van Royen N, Escaned J, Siebes M, Kirkeeide RL, Gould KL, Johnson NP, Piek JJ, Kakuta T. Coronary Flow Capacity to Identify Stenosis Associated With Coronary Flow Improvement After Revascularization: A Combined Analysis From DEFINE FLOW and IDEAL. J Am Heart Assoc. 2020 Jul 21;9(14):e016130. doi: 10.1161/JAHA.120.016130. Epub 2020 Jul 14.
PubMed 32660310Stegehuis VE, Wijntjens GWM, van de Hoef TP, Casadonte L, Kirkeeide RL, Siebes M, Spaan JAE, Gould KL, Johnson NP, Piek JJ. Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect-combined pressure and Doppler FLOW velocity measurements (DEFINE-FLOW) trial: Rationale and trial design. Am Heart J. 2020 Apr;222:139-146. doi: 10.1016/j.ahj.2019.08.018. Epub 2019 Sep 1.
PubMed 32062172Gould KL, Johnson NP, Roby AE, Nguyen T, Kirkeeide R, Haynie M, Lai D, Zhu H, Patel MB, Smalling R, Arain S, Balan P, Nguyen T, Estrera A, Sdringola S, Madjid M, Nascimbene A, Loyalka P, Kar B, Gregoric I, Safi H, McPherson D. Regional, Artery-Specific Thresholds of Quantitative Myocardial Perfusion by PET Associated with Reduced Myocardial Infarction and Death After Revascularization in Stable Coronary Artery Disease. J Nucl Med. 2019 Mar;60(3):410-417. doi: 10.2967/jnumed.118.211953. Epub 2018 Aug 16.
PubMed 30115688Matsumura M, Johnson NP, Fearon WF, Mintz GS, Stone GW, Oldroyd KG, De Bruyne B, Pijls NHJ, Maehara A, Jeremias A. Accuracy of Fractional Flow Reserve Measurements in Clinical Practice: Observations From a Core Laboratory Analysis. JACC Cardiovasc Interv. 2017 Jul 24;10(14):1392-1401. doi: 10.1016/j.jcin.2017.03.031.
PubMed 28728652Johnson NP, Gould KL, Di Carli MF, Taqueti VR. Invasive FFR and Noninvasive CFR in the Evaluation of Ischemia: What Is the Future? J Am Coll Cardiol. 2016 Jun 14;67(23):2772-2788. doi: 10.1016/j.jacc.2016.03.584.
PubMed 27282899Gould KL, Johnson NP. Coronary Blood Flow After Acute MI: Alternative Truths. JACC Cardiovasc Interv. 2016 Mar 28;9(6):614-7. doi: 10.1016/j.jcin.2016.02.009. No abstract available.
PubMed 27013162
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEFINE-FLOW (Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect - Combined Pressure and Doppler FLOW Velocity Measurements)
- ClinicalTrials.gov ID
- NCT02328820
- Acronym / sponsor ID
- DEFINE-FLOW / HSC-MS-14-0442
- Conditions
- Coronary Artery Disease
- Keywords
- Fractional Flow Reserve, Myocardial, Coronary Flow Reserve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Volcano Corporation
- Study start
- Oct 2014 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the prognostic value and therapeutic potential of combined pressure and flow measurements when evaluating a coronary artery stenosis. Lesions with intact coronary flow reserve (CFR) despite a reduced fractional flow reserve (FFR) will receive optimal medical therapy. Only lesions with a simultaneous reduction in both CFR and FFR will be treated with percutaneous coronary intervention (PCI).
Detailed description
Pressure and flow represent the two physiologic variables that can be measured directly inside a coronary artery. Already pressure measurements have proven their clinical value in the form of fractional flow reserve (FFR). However, myocardial function can remain intact with sufficient flow, even at a low perfusion pressure. Therefore, combined pressure and flow measurements provide a more complete description of physiologic stenosis severity as a guide to medical treatment versus revascularization. Based on existing work relating the most common flow measurement, coronary flow reserve (CFR), to FFR and linking both variables with subsequent prognosis, we hypothesize that lesions with an intact CFR>=2.0 can be reasonably treated with medical therapy despite a reduced FFR<=0.8.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Other: Percutaneous coronary intervention (PCI), Other: Optimal medical therapy (OMT)All lesions undergo simultaneous assessment with a combined pressure and flow sensor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years.
- Eligible for PCI based on local practice standards during the current procedure (PCI cannot be staged).
- At least one epicardial stenosis of ≥50% diameter (by visual or quantitative assessment) and meeting the following criteria as determined by the operator based on either a prior or the current diagnostic angiogram:
- Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (17 listed)
- Anatomic exclusions:
- Clinical exclusions:
- General exclusions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary intervention (PCI)For lesions with both FFR<=0.8 and CFR<2.0 | Other | All patients |
| Optimal medical therapy (OMT)For lesions with FFR>0.8 or CFR>=2.0 or both | Other | All patients |
Primary outcome
Major adverse cardiac events
Time frame: 24 months
All-cause death, non-fatal myocardial infarction, urgent and elective revascularization
1 secondary outcome
Angina (Canadian Cardiovascular Society (CCS) anginal class (or freedom from angina)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Background: PubMed 22340827Johnson NP, Kirkeeide RL, Gould KL. Is discordance of coronary flow reserve and fractional flow reserve due to methodology or clinically relevant coronary pathophysiology? JACC Cardiovasc Imaging. 2012 Feb;5(2):193-202. doi: 10.1016/j.jcmg.2011.09.020.
- Background: PubMed 24782198van de Hoef TP, van Lavieren MA, Damman P, Delewi R, Piek MA, Chamuleau SA, Voskuil M, Henriques JP, Koch KT, de Winter RJ, Spaan JA, Siebes M, Tijssen JG, Meuwissen M, Piek JJ. Physiological basis and long-term clinical outcome of discordance between fractional flow reserve and coronary flow velocity reserve in coronary stenoses of intermediate severity. Circ Cardiovasc Interv. 2014 Jun;7(3):301-11. doi: 10.1161/CIRCINTERVENTIONS.113.001049. Epub 2014 Apr 29.
- Derived from this study: PubMed 40831095Tas A, Alan Y, Tas IK, Aydin OE, Atay Z, Yilmaz S, Ozcan A, van de Hoef TP, Umman S, Piek Md JJ, Sezer M. Coronary Microvascular Dysfunction Alters the Pulsatile Behavior of the Resting Coronary Blood Flow. Microcirculation. 2025 Aug;32(6):e70021. doi: 10.1111/micc.70021.
- Derived from this study: PubMed 40417173Tas A, Alan Y, Kara Tas I, Umman S, Parker KH, van de Hoef TP, Sezer M, Piek JJ. The impact of high microvascular resistance on coronary wave energetics depends on coronary microvascular functionality. Eur Heart J Open. 2025 May 5;5(3):oeaf050. doi: 10.1093/ehjopen/oeaf050. eCollection 2025 May.
- Derived from this study: PubMed 39357645Tas A, Alan Y, Muftuogullari A, Haj Mohammad AIM, Umman S, Parker KH, Sezer M. Coronary microvascular dysfunction and autoregulatory capacity interfere with resting Dicrotic notch morphology. Microvasc Res. 2025 Jan;157:104750. doi: 10.1016/j.mvr.2024.104750. Epub 2024 Sep 30.
- Derived from this study: PubMed 37264699Achim A, Johnson NP, Liblik K, Burckhardt A, Krivoshei L, Leibundgut G. Coronary steal: how many thieves are out there? Eur Heart J. 2023 Aug 7;44(30):2805-2814. doi: 10.1093/eurheartj/ehad327.
- Derived from this study: PubMed 36640965van de Hoef TP, Stegehuis VE, Madera-Cambero MI, van Royen N, van der Hoeven NW, de Waard GA, Meuwissen M, Christiansen EH, Eftekhari A, Niccoli G, Lockie T, Matsuo H, Nakayama M, Kakuta T, Tanaka N, Casadonte L, Spaan JAE, Siebes M, Tijssen JGP, Escaned J, Piek JJ. Impact of core laboratory assessment on treatment decisions and clinical outcomes using combined fractional flow reserve and coronary flow reserve measurements - DEFINE-FLOW core laboratory sub-study. Int J Cardiol. 2023 Apr 15;377:9-16. doi: 10.1016/j.ijcard.2023.01.009. Epub 2023 Jan 11.
- Derived from this study: PubMed 35410913Eftekhari A, Westra J, Stegehuis V, Holm NR, van de Hoef TP, Kirkeeide RL, Piek JJ, Lance Gould K, Johnson NP, Christiansen EH. Prognostic value of microvascular resistance and its association to fractional flow reserve: a DEFINE-FLOW substudy. Open Heart. 2022 Apr;9(1):e001981. doi: 10.1136/openhrt-2022-001981.
- Derived from this study: PubMed 34503740Johnson NP, Collet C. Can FFR After Stenting Help Reduce Target Vessel Failure? JACC Cardiovasc Interv. 2021 Sep 13;14(17):1901-1903. doi: 10.1016/j.jcin.2021.08.001. No abstract available.
- Derived from this study: PubMed 32660310Murai T, Stegehuis VE, van de Hoef TP, Wijntjens GWM, Hoshino M, Kanaji Y, Sugiyama T, Hamaya R, Nijjer SS, de Waard GA, Echavarria-Pinto M, Knaapen P, Meuwissen M, Davies JE, van Royen N, Escaned J, Siebes M, Kirkeeide RL, Gould KL, Johnson NP, Piek JJ, Kakuta T. Coronary Flow Capacity to Identify Stenosis Associated With Coronary Flow Improvement After Revascularization: A Combined Analysis From DEFINE FLOW and IDEAL. J Am Heart Assoc. 2020 Jul 21;9(14):e016130. doi: 10.1161/JAHA.120.016130. Epub 2020 Jul 14.
- Derived from this study: PubMed 32062172Stegehuis VE, Wijntjens GWM, van de Hoef TP, Casadonte L, Kirkeeide RL, Siebes M, Spaan JAE, Gould KL, Johnson NP, Piek JJ. Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect-combined pressure and Doppler FLOW velocity measurements (DEFINE-FLOW) trial: Rationale and trial design. Am Heart J. 2020 Apr;222:139-146. doi: 10.1016/j.ahj.2019.08.018. Epub 2019 Sep 1.
- Derived from this study: PubMed 30115688Gould KL, Johnson NP, Roby AE, Nguyen T, Kirkeeide R, Haynie M, Lai D, Zhu H, Patel MB, Smalling R, Arain S, Balan P, Nguyen T, Estrera A, Sdringola S, Madjid M, Nascimbene A, Loyalka P, Kar B, Gregoric I, Safi H, McPherson D. Regional, Artery-Specific Thresholds of Quantitative Myocardial Perfusion by PET Associated with Reduced Myocardial Infarction and Death After Revascularization in Stable Coronary Artery Disease. J Nucl Med. 2019 Mar;60(3):410-417. doi: 10.2967/jnumed.118.211953. Epub 2018 Aug 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nils Johnson, MD principal investigator
University of Texas Medical School at Houston
Jan J Piek, MD, PhD study director
Academic Medical Center (AMC), Amsterdam
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention (PCI) and Optimal medical therapy (OMT) in people with Coronary Artery Disease, run by The University of Texas Health Science Center, Houston at 12 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Japan, Netherlands, Denmark, Italy, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02328820, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.