Evaluation of iFR vs FFR in Stable Angina or Acute Coronary Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02166736
• Date of registration: 07/05/2014
• Prospective Registration: No
• Primary sponsor: Uppsala University
• Public title: Evaluation of iFR vs FFR in Stable Angina or Acute Coronary Syndrome iFR Swedeheart
• Scientific title: Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome. A Multicenter, Prospective, Randomized Controlled Clinical Trial Based on the Swedish Angiography and Angioplasty Registry (SWEDEHEART) Platform
• Date of first enrolment: May 2014
• Target sample size: 2037
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02166736
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Denmark, Iceland, Sweden

Contacts

• Name: Matthias Götberg, MD,PhD
• Affiliation: Department of Cardiology, Skane University Hospital, Lund University, Lund, Sweden

• Name: Ole Fröbert, Prof
• Affiliation: Department of Cardiology, Örebro University Hospital, Örebro, Sweden

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with suspected stable angina pectoris or unstable angina
pectoris/non-ST-segment elevation myocardial infarction (NSTEMI) who are scheduled to
undergo coronary angiography, and who has an indication for physiology guided
assessment of coronary lesions (usually 30-80% stenosis grade). In patients with
suspected stable angina pectoris, any lesion may be assessed. In patients with
unstable angina pectoris/NSTEMI, only the non-culprit lesion may be assessed.

Exclusion Criteria:

- Inability to provide informed consent

- Age below 18 years

- Previous randomization in the iFR-SWEDEHEART trial

- Known terminal disease with a life expectancy of less than one year.

- In patients with multi-vessel disease and other indication than stable angina
pectoris, difficulty in assessing which the culprit lesion is.

- Patient with unstable hemodynamics (Killip class III-IV)

- Inability to tolerate Adenosine

- Previous Coronary artery bypass graft (CABG) with patent grafts to the interrogated
vessel.

- Heavily calcified or tortuous vessel where inability to cross the lesion with a
pressure wire is expected.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Myocardial Infarction

Angina Pectoris

Intervention(s)

Device: FFR

Device: iFR

Primary Outcome(s)

All cause death, non-fatal Myocardial infarction (MI), Unplanned revascularization [Time Frame: 12 months]

Secondary Outcome(s)

Unplanned revascularization [Time Frame: 1-5 years]

Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions as reported in Swedish Coronary Angiography and Angioplasty Registry (SCAAR) [Time Frame: 1-5 years]

Change in physician´s treatment strategy depending on iFR/FFR information [Time Frame: Day 1]

Procedural time [Time Frame: Day 1]

Assessment of patient discomfort during the procedure (none/mild/moderate/severe [Time Frame: Day 1]

Non-fatal MI [Time Frame: 1-5 years]

All cause death [Time Frame: 1-5 years]

Target lesion revascularization [Time Frame: 1-5 years]

Secondary ID(s)

U-2013-044

Source(s) of Monetary Support

Please refer to primary and secondary sponsors