Optimal Physiologic Intravascular Ultrasound Imaging Criteria After Drug Eluting Stent Implantation

Coronary Disease Clinical Trial

Official title:

Angiographic and IVUS Criteria Defining Physiologic Optimization By the Fractional Flow Reserve After DES Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667757
• Other study ID #: IB-2-1208-026
• Status: Completed
• Phase: N/A
• First received: August 12, 2012
• Last updated: March 23, 2015
• Start date: March 2010
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Locations

Country	Name	City	State
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang	Gyeonggido

Sponsors (2)

Lead Sponsor	Collaborator
Inje University	Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Sonoda S, Morino Y, Ako J, Terashima M, Hassan AH, Bonneau HN, Leon MB, Moses JW, Yock PG, Honda Y, Kuntz RE, Fitzgerald PJ; SIRIUS Investigators. Impact of final stent dimensions on long-term results following sirolimus-eluting stent implantation: serial intravascular ultrasound analysis from the sirius trial. J Am Coll Cardiol. 2004 Jun 2;43(11):1959-63. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences angiographic and IVUS parameters after DES between different FFR groups	Angiographic residual percent diameter stenosis (%), minimal stent lumen diameter (mm) and total stent length (mm), and IVUS minimal stent cross-sectional area (mm2) and minimal stent lumen diameter (mm) will be compared according to different FFR groups at the time of measurement after DES implantation.	baseline	No