Clinical trial NCT01667757: Optimal Physiologic Intravascular Ultrasound Imaging Criteria After Drug Eluting Stent Implantation
Official title: Angiographic and IVUS Criteria Defining Physiologic Optimization By the Fractional Flow Reserve After DES Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Keywords: coronary atherosclerosis
drug eluting stent
intravascular ultrasound
fractional flow reserve
Lead sponsor: Inje University
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
First posted: 2012-08-17
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent coronary angiography and percutaneous coronary intervention for the diagnosis and treatment purposes because of clinical angina pectoris. Patient who underwent simultaneous IVUS and FFR measurement after DES implantation would be enrolled consecutively.

Brief summary: Invasive imaging criteria of the Coronary arteriography (CAG) and intravascular ultrasound imaging (IVUS), satisfying procedural optimization after drug eluting stent (DES) implantation, were used in \< 10% DS by CAG and 5-5.5mm2 MSA by IVUS. Whether these criteria satisfy not only relieving visible stenosis but also relieving lesion specific ischemia or not were unclear. Fractional flow reserve (FFR), an index of lesion specific ischemia, was proposed 0.9 as a physiologic criteria satisfying successful stent implantation by previous studies with bare metal stent. FFR after drug-eluting stent implantation can be an useful predictor for clinical outcome. But, direct comparative evaluation of the invasive imaging criteria defining as an indicator relieving myocardial ischemia were not reported. The aim of this study was to investigate angiographic and IVUS parameters in which corresponding FFR and evaluate their optimal physiologic criteria after DES implantation.


Eligibility criteria: Inclusion Criteria:

* clinical angina pectoris who underwent IVUS and FFR during coronary angiography and after DES implantation.
* agree with informed consent
* At least one segment of three major epicardial coronary arteries were consecutively enrolled in invasive CAG.
* Post- stent FFR and IVUS measurement performed at the immediately after whole PCI procedures.

Exclusion Criteria:

* unable to get informed consent
* low left ventricular ejection fraction less than 35%
* chronic renal failure (Cr \> 2.0mg/dl)
* acute myocardial infarction related coronary artery
* allergy to adenosine injection

Primary outcomes:
measure: Differences angiographic and IVUS parameters after DES between different FFR groups
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggido
Study officials:
affiliation: Inje University Ilsan Paik Hospital
name: Joon Hyung Doh, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Doi H, Maehara A, Mintz GS, Yu A, Wang H, Mandinov L, Popma JJ, Ellis SG, Grube E, Dawkins KD, Weissman NJ, Turco MA, Ormiston JA, Stone GW. Impact of post-intervention minimal stent area on 9-month follow-up patency of paclitaxel-eluting stents: an integrated intravascular ultrasound analysis from the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Trials. JACC Cardiovasc Interv. 2009 Dec;2(12):1269-75. doi: 10.1016/j.jcin.2009.10.005.
citation: Nam CW, Rha SW, Koo BK, Doh JH, Chung WY, Yoon MH, Tahk SJ, Lee BK, Lee JB, Yoo KD, Cho YK, Chung IS, Hur SH, Kim KB, Choi CU, Oh DJ. Usefulness of coronary pressure measurement for functional evaluation of drug-eluting stent restenosis. Am J Cardiol. 2011 Jun 15;107(12):1783-6. doi: 10.1016/j.amjcard.2011.02.328. Epub 2011 Apr 8.
citation: Nam CW, Hur SH, Cho YK, Park HS, Yoon HJ, Kim H, Chung IS, Kim YN, Kim KB, Doh JH, Koo BK, Tahk SJ, Fearon WF. Relation of fractional flow reserve after drug-eluting stent implantation to one-year outcomes. Am J Cardiol. 2011 Jun 15;107(12):1763-7. doi: 10.1016/j.amjcard.2011.02.329. Epub 2011 Apr 8.