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

Unrecognized Condition Clinical Trial

Official title:

Effect of TCFA on Neointimal Coverage After EXCEL Biodegradable Polymer-coated Sirolimus-eluting Stents Implantation at 9 Months Follow-up: Evaluated by Optical Coherence Tomography and Fractional Flow Reserve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384837
• Other study ID #: Effect of TCFA
• Status: Completed
• Phase: N/A
• First received: December 25, 2014
• Last updated: December 4, 2016
• Start date: December 2014
• Est. completion date: November 2016

Study information

• Verified date: January 2015
• Source: General Hospital of Chinese Armed Police Forces
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationChina: Beijing Municipal Health Bureau
• Study type: Observational

Clinical Trial 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

Description:

The primary end point is to Neointimal coverage after 9 months of the stent implantation.

Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.

Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.

Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms, or interactive voice response systems).

Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used and normal ranges if relevant.

Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.

Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18yrs=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

Exclusion Criteria:

• 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=? 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Unrecognized Condition

Intervention

Device:
• EXCEL biodegradable polymer-coated sirolimus-eluting stent

Locations

Country	Name	City	State
China	Cardiology Department, Chinese Armed Police Force Genral Hospital, Beijing China	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Chinese Armed Police Forces

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

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 — View Citation

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 wi — View Citation

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. — View Citation

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. — View Citation

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 Eng — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Major Adverse Cardiovascular of EXCEL biodegradable polymer-coated sirolimus-eluting stent		9 months	Yes