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Study of the Natural History of FFR Guided Percutaneous Coronary Intervention

RECRUITINGSponsored by Seung-Jung Park
Actively Recruiting
SponsorSeung-Jung Park
Started2011-06
Est. completion2037-04
Eligibility
Age35 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT01366404

Summary

About 20,000 patients with FFR (Fractional Flow Reserve) will be enrolled and evaluated for the natural history of coronary lesions at 2 years clinical and imaging follow-up.

Eligibility

Age: 35 Years+Healthy volunteers accepted
Inclusion Criteria:

* Age 35 years and older
* FFR measurement on one and more coronary artery stenosis
* Willing and able to provide informed, written consent

Exclusion Criteria:

* Stenosis with TIMI\<3 flow
* Graft vessel
* Ejection fraction \< 30%
* Angiographic evidence of extreme tortuosity or calcified coronary vessels
* Suspected coronary spasm even after sufficient nitrate injected
* Life expectancy \<2 year
* Planned cardiac surgery or planned major non cardiac surgery
* Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study

Imaging study specific exclusion criteria

* visually-estimated angiographic reference segment diameter of \<2.75mm or \>4.0mm
* Inappropriate for IVUS/VH/OCT procedures : inability for imaging wire or catheter to pass through the tight stenosis, severe calcification, angulation

Conditions2

Coronary Artery DiseaseHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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