Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses

• Register: ClinicalTrials.gov
• Last refreshed on: 9 October 2023
• Main ID: NCT03497637
• Date of registration: 06/04/2018
• Prospective Registration: Yes
• Primary sponsor: Helios Health Institute GmbH
• Public title: Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses LIPSIASTRATEGY
• Scientific title: Comparison of Non-Invasive Vessel Fractional Flow Reserve Calculated From Angiographic Images Versus Fractional Flow Reserve in Patients With Intermediate Coronary Artery Stenoses
• Date of first enrolment: October 23, 2020
• Target sample size: 1926
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03497637
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Holger Thiele, MD

• Name: Holger Thiele, MD
• Affiliation: Heart Center Leipzig - University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age >18 years

- Willing to participate and able to understand, read and sign the informed consent
document before the planned procedure

- Eligible for coronary angiography and/or PCI

- Coronary artery disease in one or more native major epicardial vessels or their
branches by coronary angiogram with visually assessed de novo coronary stenosis in
which the physiological severity of the lesion is in question (typically 40-80%
diameter stenosis).

- Stable angina or acute coronary syndrome (non-culprit vessels only and outside of
primary intervention during acute STEMI or NSTE-ACS)

- Participation in another interventional study

Exclusion Criteria:

- Previous CABG with patent grafts to the interrogated vessel

- Tandem stenoses separated by more than 10 mm that require separate pressure guide wire
interrogation or PCI (not to be interrogated or treated as a single stenosis)

- Total coronary occlusions

- Hemodynamic instability (Killip class III-IV)

- Heavily calcified or tortuous vessels

- Terminal disease with life expectancy of less than 12 months

- STEMI within 48 hours of procedure

- Severe valvular heart disease

- ACS patients with difficulty in assessing which the culprit lesion is

- Significant contraindication to adenosine administration (e.g. Asthma bronchiale)

- Pregnancy



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Artery Stenoses

Coronary Artery Disease

Intervention(s)

Diagnostic Test: measurement of Pd/Pa

Diagnostic Test: measurement of FFR

Primary Outcome(s)

Major Adverse Cardiac Event (MACE) rate [Time Frame: 1 year]

Secondary Outcome(s)

Cross-over rate from the one strategy to the other [Time Frame: at intervention]

Each component of the primary endpoint assessed by structured telephone interview and verification by hospital reports [Time Frame: 1, 2 and 5 years]

MACE during long-term follow-up [Time Frame: 2 and 5 years]

Number of analyzable lesions in both treatment arms [Time Frame: at intervention]

All-cause mortality [Time Frame: 1, 2 and 5 years]

Repeat revascularization (PCI or CABG) assessed by structured telephone interview and verification by hospital reports in case of event [Time Frame: 1, 2 and 5 years]

Secondary ID(s)

HRC045277

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Heart Center Leipzig - University Hospital