Percutaneous Coronary Intervention With the Angiolite Drug-eluting Stent: an Optical Cohenrece Tomography Study

NCT02776267 | Completed DMC

• 1 other identifier: ANCHOR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to perform a first-in-man assessment of feasibility, exploratory efficacy and clinical performance of the novel Angiolite drug-eluting stent (iVascular, Barcelona, Spain) utilizing intracoronary optical coherence tomography (OCT).

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (2)

• Neo-intimal coverage

  Strut-based analysis: % of covered struts. Cross-sectional analysis: number of cross-sections with RUTTS (Rate of uncovered to total number of struts) score\>30%. Measured by an independant OCT laboratory

  6-month

• Neo-intimal obstruction

  Strut-based analysis: mean neointimal thickness (µm). Cross-sectional analysis: neointimal volume obstruction (%). Measured by an independant OCT laboratory

  6-month

Secondary Outcomes (9)

• Neo-intimal coverage

  3-month

• Neo-intimal obstruction

  3-month

• Apposition

  3- and 6-month

• In-stent angiographic late lumen in mm

  6-month

• In-stent and in-segment restenosis

  6-month

Study Arms (2)

Angiolite stent - 3-month angiogram/OCT

EXPERIMENTAL

Patients scheduled for PCI (and whot meet pre-specified inlcusion criteria) are enrolled to receive the Angiolite DES. They will undergo a scheduled repeat coronary angiogram and OCT evaluation at 3-month post index PCI.

Device: Angiolite stent

Angiolite stent - 6-month angiogram/OCT

EXPERIMENTAL

Patients scheduled for PCI (and whot meet pre-specified inlcusion criteria) are enrolled to receive the Angiolite DES. They will undergo a scheduled repeat coronary angiogram and OCT evaluation at 6-month post index PCI.

Device: Angiolite stent

Interventions

Angiolite stent DEVICE

Following index PCI, patients will be followed via scheduled clinic and/or phone contact at 1-, 3-, 6-, 12- and 24-month. Patient will be randomized to undergo a scheduled repeat coronary angiogram and OCT evaluation at either at 3- or 6-month post index PCI.

Also known as: (Angiolite CE Mark reference number: 2014 12 0833 ED)

Angiolite stent - 3-month angiogram/OCT; Angiolite stent - 6-month angiogram/OCT

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for clinically-indicated PCI of a de nove epicardial lesion, including those with chronic stable angina, ACS (defined as NSTEMI or ACS with negative cardiac enzymes) or in the setting of elective PCI.
• Indication for DES implantation
• Target lesion must have visually estimated stenosis ≥50% and one of the following: stenosis ≥70% or evidence of ischemia
• Strong preference for single stent coverage per lesion, but if unexpected clinically indicated second stent placement with overlap is needed, these patients will not be excluded from optical coherence tomographic follow-up
• Target lesion, if possible, should be predilated/pretreated

You may not qualify if:

• Age \>85 years
• Acute ST segment elevation MI (STEMI)
• Cardiogenic shock
• Known left ventricular ejection fraction \<30%
• Contraindication for dual antiplatelet therapy (DAPT) for at least 6-month duration
• Iodinated contrast allergy
• Renal impairment with serum creatinine \>2.0 mg/dL
• Anticipated medical non-compliance
• Life-expectancy \<12 months
• Chronic total occlusion (CTO) in the target vessel
• Bifurcation lesion requiring a two-stent strategy
• In-stent restenosis
• Severe lesion/segment angulation/tortuosity
• Severe vessel/lesion calcification
• Simultaneous PCI within the same or different vessel during the same procedure

Sponsors & Collaborators

• Josep Rodes-Cabau: lead
• iVascular: collaborator

Study Sites (4)

Hospital Vall D'Hebron

Barcelona, Spain

Location

Hospital Universitario de Leon

León, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Location

Related Publications (21)

• Farooq V, Gogas BD, Serruys PW. Restenosis: delineating the numerous causes of drug-eluting stent restenosis. Circ Cardiovasc Interv. 2011 Apr 1;4(2):195-205. doi: 10.1161/CIRCINTERVENTIONS.110.959882. No abstract available.

  PMID: 21505166 BACKGROUND

• Garg S, Serruys PW. Coronary stents: current status. J Am Coll Cardiol. 2010 Aug 31;56(10 Suppl):S1-42. doi: 10.1016/j.jacc.2010.06.007.

  PMID: 20797502 BACKGROUND

• Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007 Feb 24;369(9562):667-78. doi: 10.1016/S0140-6736(07)60314-6.

  PMID: 17321312 BACKGROUND

• Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, Gold HK, Burke AP, Kolodgie FD, Virmani R. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation. 2008 Sep 9;118(11):1138-45. doi: 10.1161/CIRCULATIONAHA.107.762047. Epub 2008 Aug 25.

  PMID: 18725485 BACKGROUND

• Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hebert K, Veldhof S, Webster M, Thuesen L, Dudek D. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009 Mar 14;373(9667):897-910. doi: 10.1016/S0140-6736(09)60325-1.

  PMID: 19286089 BACKGROUND

• Prati F, Guagliumi G, Mintz GS, Costa M, Regar E, Akasaka T, Barlis P, Tearney GJ, Jang IK, Arbustini E, Bezerra HG, Ozaki Y, Bruining N, Dudek D, Radu M, Erglis A, Motreff P, Alfonso F, Toutouzas K, Gonzalo N, Tamburino C, Adriaenssens T, Pinto F, Serruys PW, Di Mario C; Expert's OCT Review Document. Expert review document part 2: methodology, terminology and clinical applications of optical coherence tomography for the assessment of interventional procedures. Eur Heart J. 2012 Oct;33(20):2513-20. doi: 10.1093/eurheartj/ehs095. Epub 2012 May 31. No abstract available.

  PMID: 22653335 BACKGROUND

• Tearney GJ, Regar E, Akasaka T, Adriaenssens T, Barlis P, Bezerra HG, Bouma B, Bruining N, Cho JM, Chowdhary S, Costa MA, de Silva R, Dijkstra J, Di Mario C, Dudek D, Falk E, Feldman MD, Fitzgerald P, Garcia-Garcia HM, Gonzalo N, Granada JF, Guagliumi G, Holm NR, Honda Y, Ikeno F, Kawasaki M, Kochman J, Koltowski L, Kubo T, Kume T, Kyono H, Lam CC, Lamouche G, Lee DP, Leon MB, Maehara A, Manfrini O, Mintz GS, Mizuno K, Morel MA, Nadkarni S, Okura H, Otake H, Pietrasik A, Prati F, Raber L, Radu MD, Rieber J, Riga M, Rollins A, Rosenberg M, Sirbu V, Serruys PW, Shimada K, Shinke T, Shite J, Siegel E, Sonoda S, Suter M, Takarada S, Tanaka A, Terashima M, Thim T, Uemura S, Ughi GJ, van Beusekom HM, van der Steen AF, van Es GA, van Soest G, Virmani R, Waxman S, Weissman NJ, Weisz G; International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT). Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. J Am Coll Cardiol. 2012 Mar 20;59(12):1058-72. doi: 10.1016/j.jacc.2011.09.079. Erratum In: J Am Coll Cardiol. 2012 May 1;59(18):1662. Dudeck, Darius [corrected to Dudek, Darius]; Falk, Erlin [corrected to Falk, Erling]; Garcia, Hector [corrected to Garcia-Garcia, Hector M]; Sonada, Shinjo [corrected to Sonoda, Shinjo]; Troels, Thim [corrected to Thim, Troels]; van Es, Gerrit-Ann [correct.

  PMID: 22421299 BACKGROUND

• Suzuki Y, Ikeno F, Koizumi T, Tio F, Yeung AC, Yock PG, Fitzgerald PJ, Fearon WF. In vivo comparison between optical coherence tomography and intravascular ultrasound for detecting small degrees of in-stent neointima after stent implantation. JACC Cardiovasc Interv. 2008 Apr;1(2):168-73. doi: 10.1016/j.jcin.2007.12.007.

  PMID: 19463295 BACKGROUND

• Murata A, Wallace-Bradley D, Tellez A, Alviar C, Aboodi M, Sheehy A, Coleman L, Perkins L, Nakazawa G, Mintz G, Kaluza GL, Virmani R, Granada JF. Accuracy of optical coherence tomography in the evaluation of neointimal coverage after stent implantation. JACC Cardiovasc Imaging. 2010 Jan;3(1):76-84. doi: 10.1016/j.jcmg.2009.09.018. Epub 2010 Jan 12.

  PMID: 20129535 BACKGROUND

• Templin C, Meyer M, Muller MF, Djonov V, Hlushchuk R, Dimova I, Flueckiger S, Kronen P, Sidler M, Klein K, Nicholls F, Ghadri JR, Weber K, Paunovic D, Corti R, Hoerstrup SP, Luscher TF, Landmesser U. Coronary optical frequency domain imaging (OFDI) for in vivo evaluation of stent healing: comparison with light and electron microscopy. Eur Heart J. 2010 Jul;31(14):1792-801. doi: 10.1093/eurheartj/ehq168. Epub 2010 Jun 5.

  PMID: 20525979 BACKGROUND

• Gutierrez-Chico JL, van Geuns RJ, Regar E, van der Giessen WJ, Kelbaek H, Saunamaki K, Escaned J, Gonzalo N, di Mario C, Borgia F, Nuesch E, Garcia-Garcia HM, Silber S, Windecker S, Serruys PW. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All Comers trial. Eur Heart J. 2011 Oct;32(19):2454-63. doi: 10.1093/eurheartj/ehr182. Epub 2011 Jun 9.

  PMID: 21659439 BACKGROUND

• Toledano Delgado FJ, Alvarez-Ossorio MP, de Lezo Cruz-Conde JS, Bellido FM, Romero Moreno MA, Fernandez-Aceytuno AM, de Lezo Herrerosde Tejada JS, Pineda SO, Saint-Gerons JM, Pavlovic D. Optical coherence tomography evaluation of late strut coverage patterns between first-generation drug-eluting stents and everolimus-eluting stent. Catheter Cardiovasc Interv. 2014 Nov 1;84(5):720-6. doi: 10.1002/ccd.25235. Epub 2013 Oct 31.

  PMID: 24174291 BACKGROUND

• Kim JS, Jang IK, Kim JS, Kim TH, Takano M, Kume T, Hur NW, Ko YG, Choi D, Hong MK, Jang Y. Optical coherence tomography evaluation of zotarolimus-eluting stents at 9-month follow-up: comparison with sirolimus-eluting stents. Heart. 2009 Dec;95(23):1907-12. doi: 10.1136/hrt.2009.167759. Epub 2009 Jun 16.

  PMID: 19535352 BACKGROUND

• Chieffo A, Buchanan GL, Parodi G, Versaci F, Bianchi RM, Valenti R, Sacca S, Mongiardo A, Span S, Migliorini A, Spaccarotella C, Reimers B, Antoniucci D, Indolfi C, Ferrari A, Maehara A, Mintz GS, Colombo A. Drug-eluting stent implantation in patients with acute coronary syndrome - the Activity of Platelets after Inhibition and Cardiovascular Events: Optical Coherence Tomography (APICE OCT) study. EuroIntervention. 2014 Dec;10(8):916-23. doi: 10.4244/EIJY14M06_10.

  PMID: 24974806 BACKGROUND

• Verheye S, Ormiston JA, Stewart J, Webster M, Sanidas E, Costa R, Costa JR Jr, Chamie D, Abizaid AS, Pinto I, Morrison L, Toyloy S, Bhat V, Yan J, Abizaid A. A next-generation bioresorbable coronary scaffold system: from bench to first clinical evaluation: 6- and 12-month clinical and multimodality imaging results. JACC Cardiovasc Interv. 2014 Jan;7(1):89-99. doi: 10.1016/j.jcin.2013.07.007. Epub 2013 Oct 16.

  PMID: 24139932 BACKGROUND

• Kim JS, Jang IK, Fan C, Kim TH, Kim JS, Park SM, Choi EY, Lee SH, Ko YG, Choi D, Hong MK, Jang Y. Evaluation in 3 months duration of neointimal coverage after zotarolimus-eluting stent implantation by optical coherence tomography: the ENDEAVOR OCT trial. JACC Cardiovasc Interv. 2009 Dec;2(12):1240-7. doi: 10.1016/j.jcin.2009.10.006.

  PMID: 20129551 BACKGROUND

• Qian J, Zhang YJ, Xu B, Yang YJ, Yan HB, Sun ZW, Zhao YL, Tang YD, Gao Z, Chen J, Cui JG, Mintz GS, Gao RL. Optical coherence tomography assessment of a PLGA-polymer with electro-grafting base layer versus a PLA-polymer sirolimus-eluting stent at three-month follow-up: the BuMA-OCT randomised trial. EuroIntervention. 2014 Nov;10(7):806-14. doi: 10.4244/EIJY14M07_17.

  PMID: 25033105 BACKGROUND

• Prati F, Romagnoli E, Valgimigli M, Burzotta F, De Benedictis M, Ramondo A, Mehran R, Stella PR. Randomized comparison between 3-month Cre8 DES vs. 1-month Vision/Multilink8 BMS neointimal coverage assessed by OCT evaluation: the DEMONSTRATE study. Int J Cardiol. 2014 Oct 20;176(3):904-9. doi: 10.1016/j.ijcard.2014.08.031. Epub 2014 Aug 13.

  PMID: 25171966 BACKGROUND

• Mauri L, Kereiakes DJ, Yeh RW, Driscoll-Shempp P, Cutlip DE, Steg PG, Normand SL, Braunwald E, Wiviott SD, Cohen DJ, Holmes DR Jr, Krucoff MW, Hermiller J, Dauerman HL, Simon DI, Kandzari DE, Garratt KN, Lee DP, Pow TK, Ver Lee P, Rinaldi MJ, Massaro JM; DAPT Study Investigators. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med. 2014 Dec 4;371(23):2155-66. doi: 10.1056/NEJMoa1409312. Epub 2014 Nov 16.

  PMID: 25399658 BACKGROUND

• Colombo A, Chieffo A, Frasheri A, Garbo R, Masotti-Centol M, Salvatella N, Oteo Dominguez JF, Steffanon L, Tarantini G, Presbitero P, Menozzi A, Pucci E, Mauri J, Cesana BM, Giustino G, Sardella G. Second-generation drug-eluting stent implantation followed by 6- versus 12-month dual antiplatelet therapy: the SECURITY randomized clinical trial. J Am Coll Cardiol. 2014 Nov 18-25;64(20):2086-97. doi: 10.1016/j.jacc.2014.09.008. Epub 2014 Sep 15.

  PMID: 25236346 BACKGROUND

• Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for Universal Definition of Myocardial Infarction; Authors/Task Force Members Chairpersons; Thygesen K, Alpert JS, White HD; Biomarker Subcommittee; Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA; ECG Subcommittee; Chaitman BR, Clemmensen PM, Johanson P, Hod H; Imaging Subcommittee; Underwood R, Bax JJ, Bonow JJ, Pinto F, Gibbons RJ; Classification Subcommittee; Fox KA, Atar D, Newby LK, Galvani M, Hamm CW; Intervention Subcommittee; Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J; Trials & Registries Subcommittee; Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML; Trials & Registries Subcommittee; Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G; Trials & Registries Subcommittee; Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D; Trials & Registries Subcommittee; Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG); Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S; Document Reviewers; Morais J, Aguiar C, Almahmeed W, Arnar DO, Barili F, Bloch KD, Bolger AF, Botker HE, Bozkurt B, Bugiardini R, Cannon C, de Lemos J, Eberli FR, Escobar E, Hlatky M, James S, Kern KB, Moliterno DJ, Mueller C, Neskovic AN, Pieske BM, Schulman SP, Storey RF, Taubert KA, Vranckx P, Wagner DR. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012 Oct 16;60(16):1581-98. doi: 10.1016/j.jacc.2012.08.001. Epub 2012 Sep 5. No abstract available.

  PMID: 22958960 BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Josep Rodes-Cabau, MD

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 7, 2016
• First Posted: May 18, 2016
• Study Start: May 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

ES (4)