Ischemic Heart DiseasePhase 3FORZANCT01824030

FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty

A Phase 3 study testing FFR guided PCI and OCT guided PCI in people with Ischemic Heart Disease, run by Catholic University of the Sacred Heart at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Ischemic Heart Disease
What is being tested?: FFR guided PCI and OCT guided PCI
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 1 siteItaly
Study dates: Apr 2013to Apr 2016
Phase: Phase 3
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

single vessel disease with an intermediate coronary artery stenosis
multivessel disease with multiple intermediate coronary artery stenosis only
multivessel disease with already treated angiographically critical stenosis and at least one intermediate coronary artery stenosis

Who cannot join

age <18 years or impossibility to give informed consent,
female sex with child-bearing potential,
life expectancy of less than 12 months or factors making clinical follow-up difficult (no fixed address, etc),
poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%
recent (< 7 days) ST-segment elevation myocardial infarction
recent (< 48 hours) Non ST-segment elevation myocardial infarction

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prior ST-segment elevation myocardial infarction in the territory supplied by the vessel with the intermediate stenosis under investigation
severe myocardial hypertrophy (interventricular septum thickness > 15 mm, ECG Sokolow's criteria fulfilled)
severe valvular heart disease
significant platelet count alteration (<100,000 cells/mm3 or > 700,000 cells/mm3)
gastrointestinal bleeding requiring surgery or blood transfusions within 4 previous weeks
history of clotting pathology
known hypersensitivity to aspirin, heparin, contrast dye
advance renal failure with glomerular filtration rate < 30 ml/min
lesions in coronary artery bypass grafts
multivessel disease requiring coronary aortic bypass graft intervention

Trial locations and contacts

1 site in 1 country.

Francesco Burzotta, MD, PhD contact

+39 3494295290

f.burzotta@rm.unicatt.it

Italy1 site, 1 recruiting

Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
Rome, 00168
Francesco Burzotta, MD, PhD, 349-429-5290 ext. +39, f.burzotta@rm.unicatt.it
Francesco Burzotta, MD, PhD
Recruiting

Other trials in Italy

About this study

Whether to revascularize patients with angiographically-intermediate coronary lesions (AICL) is a major clinical issue. Intravascular techniques (assessing either the anatomy or the functional effect of coronary stenoses) are routinely used to better characterize coronary lesions. Among these,fractional flow reserve (FFR) provides validated functional insights while optical coherence tomography (OCT) provides high resolution anatomic imaging. Both techniques may be applied to guide decisions regarding the opportunity to revascularize patients with AICL and to optimize the result of percutaneous coronary intervention (PCI). We aim to compare the clinical and the economical impact of FFR versus OCT guidance in the percutaneous management of patients with AICL.

Conditions: Ischemic Heart Disease
Being tested: FFR guided PCI, OCT guided PCI
Keywords: FFR, OCT, Seattle Angina Questionnaire
Medical subject headings: Myocardial Ischemia, Ornithine Carbamoyltransferase Deficiency Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FFR guided PCIDevice
FFR to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention
OCT guided PCIDevice
OCT to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention

Study groups in NCT01824030
Study group	Role	What they receive
FFR guided PCI arm	Active comparator	Patients with angiographic intermediate coronary artery stenosis randomized to FFR assessment. PCI performed only if FFR ≤ 0.80 Receives: Device: FFR guided PCI
OCT guided PCI arm	Active comparator	Patients with angiographic intermediate coronary artery stenosis randomized to OCT. PCI will be performed if: 1. percentage area stenosis ≥75 % 2. percentage area stenosis between 50 and 75% and minimal lumen area <2.5 mm2 3. percentage area stenosis between 50 and 75% and major plaque ulceration Receives: Device: OCT guided PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of angina defined as Seattle Angina Questionnaire score < 90 in angina frequency scale, at 13 month follow up from index procedure*
*In case of MACE rate absolute difference of >1% between the two study arms, the primary end-point will be: "Occurrence of Major Cardiovascular Event and angina defined as Seattle Angina Questionnaire score < 90 in angina frequency scale, at 13 months follow up from index procedure"
Measured: 13 months

Secondary outcomes (1)

Occurrence of Major Cardiovascular Event and angina defined as Seattle Angina Questionnaire score < 90 in angina frequency scale, at 13 months follow up from index procedure
Measured: 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Apr 2016

First posted4 Apr 2013 (estimated)
Study startApr 2013
Primary completionApr 2016 (estimated)
Study completionApr 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01824030
Sponsor's protocol ID: 6261/13
Acronym: FORZA
Status last verified: Apr 2013
First submitted: 28 Mar 2013
Last updated: 9 Apr 2013
Results posted: No

Publications

Aurigemma C, Ding D, Tu S, Li C, Yu W, Li Y, Leone AM, Romagnoli E, Vergallo R, Maino A, Trani C, Wijns W, Burzotta F. Three-Year Clinical Impact of Murray Law-Based Quantitative Flow Ratio and OCT- or FFR-Guidance in Angiographically Intermediate Coronary Lesions. Circ Cardiovasc Interv. 2024 May;17(5):e013191. doi: 10.1161/CIRCINTERVENTIONS.123.013191. Epub 2024 Apr 25.
PubMed 38660794
Ding D, Tu S, Li Y, Li C, Yu W, Liu X, Leone AM, Aurigemma C, Romagnoli E, Vergallo R, Trani C, Wijns W, Burzotta F. Quantitative flow ratio modulated by intracoronary optical coherence tomography for predicting physiological efficacy of percutaneous coronary intervention. Catheter Cardiovasc Interv. 2023 Jul;102(1):36-45. doi: 10.1002/ccd.30681. Epub 2023 May 12.
PubMed 37172214
Burzotta F, Leone AM, Aurigemma C, Zambrano A, Zimbardo G, Arioti M, Vergallo R, De Maria GL, Cerracchio E, Romagnoli E, Trani C, Crea F. Fractional Flow Reserve or Optical Coherence Tomography to Guide Management of Angiographically Intermediate Coronary Stenosis: A Single-Center Trial. JACC Cardiovasc Interv. 2020 Jan 13;13(1):49-58. doi: 10.1016/j.jcin.2019.09.034.
PubMed 31918942
Leone AM, Burzotta F, Aurigemma C, De Maria GL, Zambrano A, Zimbardo G, Arioti M, Cerracchio E, Vergallo R, Trani C, Crea F. Prospective Randomized Comparison of Fractional Flow Reserve Versus Optical Coherence Tomography to Guide Revascularization of Intermediate Coronary Stenoses: One-Month Results. J Am Heart Assoc. 2019 Aug 6;8(15):e012772. doi: 10.1161/JAHA.119.012772. Epub 2019 Jul 23.
PubMed 31331219
Burzotta F, Leone AM, De Maria GL, Niccoli G, Coluccia V, Pirozzolo G, Saffioti S, Aurigemma C, Trani C, Crea F. Fractional flow reserve or optical coherence tomography guidance to revascularize intermediate coronary stenosis using angioplasty (FORZA) trial: study protocol for a randomized controlled trial. Trials. 2014 Apr 23;15:140. doi: 10.1186/1745-6215-15-140.
PubMed 24758510

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty
ClinicalTrials.gov ID: NCT01824030
Acronym / sponsor ID: FORZA / 6261/13
Conditions: Ischemic Heart Disease
Keywords: FFR, OCT, Seattle Angina Questionnaire
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 400 participants (estimated)
Lead sponsor: Catholic University of the Sacred HeartUniversity, hospital or other
Study start: Apr 2013
Primary completion: Apr 2016 (estimated)
Study completion: Apr 2016 (estimated)
First posted: 4 Apr 2013 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
FFR guided PCI arm	Active comparator	Device: FFR guided PCIPatients with angiographic intermediate coronary artery stenosis randomized to FFR assessment. PCI performed only if FFR ≤ 0.80
OCT guided PCI arm	Active comparator	Device: OCT guided PCIPatients with angiographic intermediate coronary artery stenosis randomized to OCT. PCI will be performed if: 1. percentage area stenosis ≥75 % 2. percentage area stenosis between 50 and 75% and minimal lumen area <2.5 mm2 3. percentage area stenosis between 50 and 75% and major plaque ulceration

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

single vessel disease with an intermediate coronary artery stenosis
multivessel disease with multiple intermediate coronary artery stenosis only
multivessel disease with already treated angiographically critical stenosis and at least one intermediate coronary artery stenosis

Key exclusion criteria (16 listed)

age <18 years or impossibility to give informed consent,
female sex with child-bearing potential,
life expectancy of less than 12 months or factors making clinical follow-up difficult (no fixed address, etc),
poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%
recent (< 7 days) ST-segment elevation myocardial infarction

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
FFR guided PCIFFR to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention	Device	FFR guided PCI arm
OCT guided PCIOCT to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention	Device	OCT guided PCI arm

Primary outcome

Occurrence of angina defined as Seattle Angina Questionnaire score < 90 in angina frequency scale, at 13 month follow up from index procedure*
Time frame: 13 months
*In case of MACE rate absolute difference of >1% between the two study arms, the primary end-point will be: "Occurrence of Major Cardiovascular Event and angina defined as Seattle Angina Questionnaire score < 90 in angina frequency scale, at 13 months follow up from index procedure"

1 secondary outcome

Occurrence of Major Cardiovascular Event and angina defined as Seattle Angina Questionnaire score < 90 in angina frequency scale, at 13 months follow up from index procedure
Time frame: 13 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
Derived from this study: PubMed 38660794Aurigemma C, Ding D, Tu S, Li C, Yu W, Li Y, Leone AM, Romagnoli E, Vergallo R, Maino A, Trani C, Wijns W, Burzotta F. Three-Year Clinical Impact of Murray Law-Based Quantitative Flow Ratio and OCT- or FFR-Guidance in Angiographically Intermediate Coronary Lesions. Circ Cardiovasc Interv. 2024 May;17(5):e013191. doi: 10.1161/CIRCINTERVENTIONS.123.013191. Epub 2024 Apr 25.
Derived from this study: PubMed 37172214Ding D, Tu S, Li Y, Li C, Yu W, Liu X, Leone AM, Aurigemma C, Romagnoli E, Vergallo R, Trani C, Wijns W, Burzotta F. Quantitative flow ratio modulated by intracoronary optical coherence tomography for predicting physiological efficacy of percutaneous coronary intervention. Catheter Cardiovasc Interv. 2023 Jul;102(1):36-45. doi: 10.1002/ccd.30681. Epub 2023 May 12.
Derived from this study: PubMed 31918942Burzotta F, Leone AM, Aurigemma C, Zambrano A, Zimbardo G, Arioti M, Vergallo R, De Maria GL, Cerracchio E, Romagnoli E, Trani C, Crea F. Fractional Flow Reserve or Optical Coherence Tomography to Guide Management of Angiographically Intermediate Coronary Stenosis: A Single-Center Trial. JACC Cardiovasc Interv. 2020 Jan 13;13(1):49-58. doi: 10.1016/j.jcin.2019.09.034.
Derived from this study: PubMed 31331219Leone AM, Burzotta F, Aurigemma C, De Maria GL, Zambrano A, Zimbardo G, Arioti M, Cerracchio E, Vergallo R, Trani C, Crea F. Prospective Randomized Comparison of Fractional Flow Reserve Versus Optical Coherence Tomography to Guide Revascularization of Intermediate Coronary Stenoses: One-Month Results. J Am Heart Assoc. 2019 Aug 6;8(15):e012772. doi: 10.1161/JAHA.119.012772. Epub 2019 Jul 23.
Derived from this study: PubMed 24758510Burzotta F, Leone AM, De Maria GL, Niccoli G, Coluccia V, Pirozzolo G, Saffioti S, Aurigemma C, Trani C, Crea F. Fractional flow reserve or optical coherence tomography guidance to revascularize intermediate coronary stenosis using angioplasty (FORZA) trial: study protocol for a randomized controlled trial. Trials. 2014 Apr 23;15:140. doi: 10.1186/1745-6215-15-140.

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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.

Francesco Burzotta, MD, PhD contact

+39 3494295290

f.burzotta@rm.unicatt.it

Francesco Burzotta, MD, PhD principal investigator

Università Cattolica del Sacro Cuore, Roma

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FFR guided PCI and OCT guided PCI in people with Ischemic Heart Disease, run by Catholic University of the Sacred Heart at 1 site in Italy.

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 3 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Francesco Burzotta, MD, PhD (+39 3494295290, f.burzotta@rm.unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of angina defined as Seattle Angina Questionnaire score < 90 in angina frequency scale, at 13 month follow up from index procedure* (time frame: 13 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 NCT01824030, which also lists 5 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 9 Apr 2013.