Effect of TCFA on Neointimal Coverage After PCI at 9 Months Follow-up

NCT02384837 | Completed DMC

• 1 other identifier: Effect of TCFA
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Although drug-eluting stents have reduced rates of restenosis and late lumen loss compared with bare metal stents, late stent thrombosis (LST), a life-threatening complication of this technology, has emerged as a major concern. Researches indicated incomplete neointimal coverage of stent struts as the most important morphometric predictor of LST. Pathological research showed stenting disruption of adjacent vulnerable plaques can precipitate LST, Meanwhile, thin-cap fibroatheromas (TCFA) as the most important predictor of Major Adverse Cardiovascular. Therefore, there is a hypothesis that TCFA may impair intimal healing which are prone to LST in vivo. Optical coherence tomography (OCT)is a high-resolution (\<10 µm), catheter-based imaging modality capable of investigating detailed coronary plaque morphology in vivo.This study aimed to observe that TCFA will arise what of the effect on intimal healing of stent struts on the lesions which fractional flow reserve (FFR)≤0.75 after EXCEL biodegradable polymer-coated sirolimus-eluting stent was implanted at 9 months follow up: evaluated by OCT and FFR

Conditions

Unrecognized Condition

Keywords

national Cather Lad; Interventional Imaging Training Base

Outcome Measures

Primary Outcomes (1)

• Neointimal coverage of EXCEL biodegradable polymer-coated sirolimus-eluting stent

  offline OCT analysis will be performed independently by 2 investigators blinded to patient characteristics and to the stent used. Proprietary software will be used to analyze cross-sections at 1-mm intervals(every 5 frames) within the stented segment. In each cross-section, the number of struts was counted. Struts were classified as uncovered if any part of the strut was visibly exposed to the lumen, or covered if a layer of tissue was visible all over the reflecting surfaces.

  9 months

Secondary Outcomes (1)

• Major Adverse Cardiovascular of EXCEL biodegradable polymer-coated sirolimus-eluting stent

  9 months

Study Arms (2)

TCFA

EXCEL biodegradable polymer-coated sirolimus-eluting stent was implanted on lesions which include TCFA (\>=1)

Device: EXCEL biodegradable polymer-coated sirolimus-eluting stent

NO-TCFA

EXCEL biodegradable polymer-coated sirolimus-eluting stent was implanted on lesions which is not include TCFA

Device: EXCEL biodegradable polymer-coated sirolimus-eluting stent

Interventions

EXCEL biodegradable polymer-coated sirolimus-eluting stent DEVICE

NO-TCFA; TCFA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will plan for a total of 55 patients with Non ST-ACS (all of the patients was selected in different blood vessels, a total of up to two target disease Variable and each target lesion 1 stents, such as placing stents need more than one in the operation, require the use of EXCEL stents, mix does not recommend the same patients Other brand support, unless save extra stents.) Choose lesions reference diameter of 2.5 mm to 4.0 mm (visual), each lesion length 32 mm or less (visual), participants must conform to the standard can be selected.

You may qualify if:

• yrs≤Age≤75yrs
• stability and unstable angina pectoris (AP), chronic myocardial infarction (OMI) or confirmed myocardial ischemia
• De novo lesion at native coronary artery(Up to two target lesions)
• Lesion length ≤32mm
• RVD 2.5mm～4.0mm
• DS%≥70% by visual test
• Coronary artery bypass surgery (coronary artery bypass grafting) patients
• Subjects are willing to follow the specified requirements follow-up
• To understand the purpose of the trial and willing to sign informed consent and accept clinical follow-up

You may not qualify if:

• AMI within 7 days.
• CTO (TIMI 0), the left main lesion, ostial lesion and transplant vascular lesions, the bifurcation lesion (reference collateral blood vessel diameter of 2.5 mm or higher), stent restenosis lesions and to deal with three pathological changes;
• Severe calcified lesion unable to predilate.
• The distortion of the stent was hampered by lesions.
• NYHA≥Ⅲ or LVEF\<40%.
• Prior PCI within 1 year.
• Pregnancy or lactation, and planning pregnancy or lactation.
• Subjects have bleeding tendency or blood coagulation dysfunction or PCI contraindications, or anticoagulant therapy taboo or can't continue to take DAPT at least 1 year.
• There are other diseases (such as cancer,malignant tumor ,congestive heart failure,organ transplantation or candidate) or abuse history (alcohol cocaine heroin, etc.), scheme compliance is poor, interference related data explanation or the limited life (\< 1 year).
• To aspirin heparin clopidogrel cobalt chromium alloy rapamycin PLA polymer contrast agent of one of allergy.
• Serious liver and kidney function are not complete subject(ALT and AST were three times greater than the upper limit of normal).
• Before enrolling to participate in other clinical trials and not reached the primary endpoint.
• Non-compliant subject and could not finish the trial in accordance with the requirements of the subjects.

Sponsors & Collaborators

• General Hospital of Chinese Armed Police Forces: lead

Study Sites (1)

Cardiology Department, Chinese Armed Police Force Genral Hospital, Beijing China

Beijing, 100039, China

Location

Related Publications (7)

• Ozaki Y, Okumura M, Ismail TF, Naruse H, Hattori K, Kan S, Ishikawa M, Kawai T, Takagi Y, Ishii J, Prati F, Serruys PW. The fate of incomplete stent apposition with drug-eluting stents: an optical coherence tomography-based natural history study. Eur Heart J. 2010 Jun;31(12):1470-6. doi: 10.1093/eurheartj/ehq066. Epub 2010 Apr 2.

  PMID: 20363765 BACKGROUND

• Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.

  PMID: 17438147 RESULT

• Matsumoto D, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, Sawada T, Paredes OL, Hirata K, Yokoyama M. Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J. 2007 Apr;28(8):961-7. doi: 10.1093/eurheartj/ehl413. Epub 2006 Nov 29.

  PMID: 17135281 RESULT

• Kubo T, Imanishi T, Kitabata H, Kuroi A, Ueno S, Yamano T, Tanimoto T, Matsuo Y, Masho T, Takarada S, Tanaka A, Nakamura N, Mizukoshi M, Tomobuchi Y, Akasaka T. Comparison of vascular response after sirolimus-eluting stent implantation between patients with unstable and stable angina pectoris: a serial optical coherence tomography study. JACC Cardiovasc Imaging. 2008 Jul;1(4):475-84. doi: 10.1016/j.jcmg.2008.03.012.

  PMID: 19356470 RESULT

• Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358.

  PMID: 21247313 RESULT

• Farb A, Burke AP, Kolodgie FD, Virmani R. Pathological mechanisms of fatal late coronary stent thrombosis in humans. Circulation. 2003 Oct 7;108(14):1701-6. doi: 10.1161/01.CIR.0000091115.05480.B0. Epub 2003 Sep 22.

  PMID: 14504181 RESULT

• Guagliumi G, Sirbu V, Musumeci G, Bezerra HG, Aprile A, Kyono H, Fiocca L, Matiashvili A, Lortkipanidze N, Vassileva A, Popma JJ, Allocco DJ, Dawkins KD, Valsecchi O, Costa MA. Strut coverage and vessel wall response to a new-generation paclitaxel-eluting stent with an ultrathin biodegradable abluminal polymer: Optical Coherence Tomography Drug-Eluting Stent Investigation (OCTDESI). Circ Cardiovasc Interv. 2010 Aug;3(4):367-75. doi: 10.1161/CIRCINTERVENTIONS.110.950154. Epub 2010 Jul 20.

  PMID: 20647562 RESULT

Study Officials

• HUILIANG LIU, MD

  CHINESE ARMED POLICE FORCE GENRAL HOSPITAL

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2014
• First Posted: March 10, 2015
• Study Start: December 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 6, 2016

Record last verified: 2015-01

Locations

CN (1)