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Coronary Heart DiseaseNCT02776267

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

A study testing Angiolite stent in people with Coronary Heart Disease, run by Josep Rodes-Cabau at 4 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Coronary Heart Disease
What is being tested?
Angiolite stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesSpain
Study dates
May 2015to Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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
  • Lesion unsuitable for OCT (proximal lesions <10 mm from ostium of left main or right coronary arteries)
  • Lesion length >18 mm
  • Stent length >24 mm
  • Stent diameter ≤2.5 mm and > 4.0 mm
  • Unprotected left main coronary artery disease (≥50% diameter stenosis)
  • >1 lesion
  • Planned use of 2 overlapping stents

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

  • Hospital Vall D'Hebron

    Barcelona

  • Hospital Universitario de Leon

    León

  • Hospital Clinico San Carlos

    Madrid

  • Hospital Universitario Marqués de Valdecilla

    Santander

Other trials in Spain

About this study

Official title: Percutaneous Coronary Intervention With the ANgiolite Drug-Eluting Stent: an Optical CoHerence TOmogRaphy Study. The ANCHOR Study

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).

Read the detailed description

This is a prospective registry including patient scheduled for a clinically-indicated percutaneous coronary intervention (PCI) of a de novo epicardial lesion with indication for drug-eluting stent implantation. Following study enrolment and PCI/stent with the Angiolite DES, patients will be scheduled for follow-up surveillance coronary angiography and OCT with the C7-XRTM Fourier Domain OCT system with C7 DragonflyTM catheter (St Jude Medical, Minneapolis, MN) or with the Terumo LunawayTM OCT system with fastview catheter (Terumo Medical Corporation, Tokyo, Japan). An adaptive design component of the study will randomize patients to either 3-month or 6-month angio/OCT follow-up. Clinical follow-up will occur at 30 days, 3 months, 6 months, 12 months and 24 months post PCI.

Being tested
Angiolite stent
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Angiolite stentDevice

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

    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.

Study groups in NCT02776267
Study groupRoleWhat they receive
Angiolite stent - 3-month angiogram/OCTExperimentalPatients 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.
Receives: Device: Angiolite stent
Angiolite stent - 6-month angiogram/OCTExperimentalPatients 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.
Receives: Device: Angiolite stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6-month

  2. Neo-intimal obstruction

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

    Measured: 6-month

Secondary outcomes (9)

  1. 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.

    Measured: 3-month

  2. Neo-intimal obstruction

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

    Measured: 3-month

  3. Apposition

    Strut-based analysis: incomplete strut apposition (ISA) rate. Cross-sectional analysis: % frames with ISA. Measured by an independant OCT laboratory.

    Measured: 3- and 6-month

  4. In-stent angiographic late lumen in mm

    Confirmed by Imaging and measured by an independant QCA laboratory

    Measured: 6-month

  5. In-stent and in-segment restenosis

    Confirmed by Imaging and measured by an independant QCA laboratory (Reduction in percent diameter stenosis of stented segment of >= 50%

    Measured: 6-month

  6. CV death

    Death from any known cardiovascular etiology

    Measured: 6-month and 1-year

  7. Myocardial infarction

    Peri-procedural myocardial infarction will be defined according to the 3rd universal definition of MI Following PCI, myocardial infarction will be defined according to the specific clinical situation of the patient.

    Measured: Peri-procedural, spontaneous

  8. Target-lesion revascularization

    Any repeat revascularization du to a restenosis within the DES-treated segment

    Measured: 24 months

  9. Binary restenosis

    Reduction in percent diameter stenosis of stented segment of < vs.>= 50%

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2016 (estimated)
  2. Study startMay 2015
  3. Primary completionJun 2017
  4. Study completionJun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02776267
Sponsor's protocol ID
ANCHOR
Status last verified
Jul 2018
First submitted
7 Feb 2016
Last updated
17 Jul 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 21505166

  • 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.

    PubMed 20797502

  • 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.

    PubMed 17321312

  • 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.

    PubMed 18725485

  • 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.

    PubMed 19286089

  • 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.

    PubMed 22653335

  • 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.

    PubMed 22421299

  • 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.

    PubMed 19463295

  • 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.

    PubMed 20129535

  • 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.

    PubMed 20525979

  • 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.

    PubMed 21659439

  • 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.

    PubMed 24174291

  • 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.

    PubMed 19535352

  • 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.

    PubMed 24974806

  • 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.

    PubMed 24139932

Questions about this trial

What is this clinical trial studying?

A study testing Angiolite stent in people with Coronary Heart Disease, run by Josep Rodes-Cabau at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neo-intimal coverage (time frame: 6-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02776267, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.

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