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Coronary Artery DiseaseNCT02785237

Intra-patient Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT (Optical Coherence Tomography) Follow up

A study testing Coroflex® ISAR Drug-eluting stent and Ultimaster® Drug-eluting stent in people with Coronary Artery Disease, run by Hospital Universitari Vall d'Hebron Research Institute at 3 sites in Spain.

Completed

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

Official record
Search all trials

Trial summary

The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Coroflex® ISAR Drug-eluting stent and Ultimaster® Drug-eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
3 sitesSpain
Study dates
Jun 2016to 1 Jan 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥ 18 years
  • Signature of informed consent
  • Patients with angina and a clinical indication for coronary revascularisation with a drug-eluting stent
  • Presence of at least 2 lesions to be revascularised with similar angiographic characteristics
  • Reference lesion diameter with at most a difference of 0.5 mm
  • Maximum difference in lesion length of 10 mm
  • Lesions able to be treated with only 1 stent

Who cannot join

  • Lesions due to restenosis
  • Lesions in saphenous vein grafts
  • STE-ACS ( ST elevation- Acute Coronary Syndrome)
  • Cardiogenic shock
  • Dual antiplatelet therapy contraindication for> 3 months
  • Follow-up catheterisation contraindicated
Show all 19Show fewer
  • Chronic kidney failure with creatinine > 2 mg/dL
  • Allergy to iodinated contrast agents
  • Serious complication from vascular access in previous catheterisation
  • Ineligible for evaluation via optical coherence tomography
  • Lesion located <5 mm from aorto-ostial junction
  • Severe proximal angulation >90º
  • Bifurcation lesion requiring a strategy with two stents
  • Angiographic characteristics that promote stent malposition
  • Aneurysm or coronary artery ectasia
  • Presence of a thrombus classed as TIMI (Thrombolysis In Myocardial Infarction )2 flow or higher
  • Severe calcification, in particular in cases of calcium spike
  • Severe lesion angulation
  • Inability to do reliable follow-up, in the investigator's opinion

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital de León

    León, 24008

Other trials in Spain

About this study

Official title: Intra-patient Randomized Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT Follow up

The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent

Read the detailed description

The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent

Being tested
Coroflex® ISAR Drug-eluting stent, Ultimaster® Drug-eluting stent
Keywords
Drug-eluting stent, OCT, Re-endothelialization
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Coroflex® ISAR Drug-eluting stentDevice

    Coroflex® ISAR Drug-eluting stent and an Ultimaster® Drug-eluting stent in the second lesion.

  • Ultimaster® Drug-eluting stentDevice

    Ultimaster® Drug-eluting stent and a Coroflex® ISAR Drug-eluting stent in the second lesion.

Study groups in NCT02785237
Study groupRoleWhat they receive
Coroflex® ISAR Drug-eluting stent in first lesionActive comparatorPatients with Coroflex® ISAR Drug-eluting stent in the first lesion
Receives: Device: Coroflex® ISAR Drug-eluting stent
Ultimaster® Drug-eluting stent in first lesionActive comparatorPatients with Ultimaster® Drug-eluting stent in first lesion
Receives: Device: Ultimaster® Drug-eluting stent
Coroflex® ISAR Drug-eluting stent in second lesionActive comparatorPatients with with Ultimaster® Drug-eluting stent in first lesion
Receives: Device: Coroflex® ISAR Drug-eluting stent
Ultimaster® Drug-eluting stent in second lesionActive comparatorPatients with Coroflex® ISAR Drug-eluting stent in the first lesion
Receives: Device: Ultimaster® Drug-eluting stent

What is being measured

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

  1. Percentage of early coating on the struts of the Coroflex® ISAR Drug-eluting stent versus Ultimaster® - Drug eluting stent at 3 months OCT after stent implantation.

    Measured: 3 months

  2. Percentage of covered struts at 3 months OCT after stent implantation.

    Measured: 3 months

  3. Percentage of stents with ≥3% of uncovered struts at 3 months OCT after stent implantation.

    Measured: 3 months

  4. Percentage of uncovered struts ≥3% at 3 months OCT after stent implantation.

    Measured: 3 months

  5. Number of transversal sections with a percentage (rate of uncovered struts/ total number of struts) > 30 % at 3 months OCT after stent implantation.

    Measured: 3 months

Secondary outcomes (10)

  1. Percentage of covered struts, at 1 month, 2 months and 3 months OCT after stent implantation.

    Measured: 1 month and 2 months and 3 months

  2. Total Tissue coverage at 1month, 2 months and 3 months OCT after stent implantation.

    Measured: 1 month and 2 months and 3 months

  3. Mean thickness of struts tissue coverage at 1 month, 2 months and 3 months OCT after stent implantation.

    Measured: 1 month and 2 months and 3 months

  4. MACE (Major Adverse Cardiac Events) at 30 days, 3 months, 6 months and 12 months.

    Measured: 30 days and 3 months and 6 months and 12 months

  5. Target lesion revascularization and target vessel revascularization at 30 days, 3 months, 6 months and 12 months OCT after stent implantation .

    Measured: 30 days and 3 months and 6 months and 12 months

  6. Percentage of stent malapposition at 1 month and 3 months OCT after stent implantation.

    Measured: 1 month and 2 months and 3 months

  7. Percentage of struts malapposition at 1 month and 3 months OCT after stent implantation.

    Measured: 1 month and 2 months and 3 months

  8. Percentage of struts malapposition> 260 µm at 1 month and 3 months OCT after stent implantation.

    Measured: 1 month and 2 months and 3 months

  9. Percentage of stents with any malapposition strut > 260 µm at 1 month and 3 months OCT after stent implantation.

    Measured: 1 month and 2 months and 3 months

  10. Healing Score at 1 month and 3 months OCT after stent implantation .

    Measured: 1 month and 2 months and 3 months

Timeline

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

  1. First posted27 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completion1 Jan 2019
  4. Study completion1 Jan 2019

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
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02785237
Sponsor's protocol ID
FRIENDLY OCT
Status last verified
Jan 2019
First submitted
20 May 2016
Last updated
3 Jan 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, Colombo A, Schampaert E, Grube E, Kirtane AJ, Cutlip DE, Fahy M, Pocock SJ, Mehran R, Leon MB. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007 Mar 8;356(10):998-1008. doi: 10.1056/NEJMoa067193. Epub 2007 Feb 12.

    PubMed 17296824

  • Kirtane AJ, Gupta A, Iyengar S, Moses JW, Leon MB, Applegate R, Brodie B, Hannan E, Harjai K, Jensen LO, Park SJ, Perry R, Racz M, Saia F, Tu JV, Waksman R, Lansky AJ, Mehran R, Stone GW. Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies. Circulation. 2009 Jun 30;119(25):3198-206. doi: 10.1161/CIRCULATIONAHA.108.826479. Epub 2009 Jun 15.

    PubMed 19528338

  • 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

  • de la Torre-Hernandez JM, Alfonso F, Hernandez F, Elizaga J, Sanmartin M, Pinar E, Lozano I, Vazquez JM, Botas J, Perez de Prado A, Hernandez JM, Sanchis J, Nodar JM, Gomez-Jaume A, Larman M, Diarte JA, Rodriguez-Collado J, Rumoroso JR, Lopez-Minguez JR, Mauri J; ESTROFA Study Group. Drug-eluting stent thrombosis: results from the multicenter Spanish registry ESTROFA (Estudio ESpanol sobre TROmbosis de stents FArmacoactivos). J Am Coll Cardiol. 2008 Mar 11;51(10):986-90. doi: 10.1016/j.jacc.2007.10.057.

    PubMed 18325436

  • Kolh P, Windecker S, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A; European Society of Cardiology Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; EACTS Clinical Guidelines Committee; Sousa Uva M, Achenbach S, Pepper J, Anyanwu A, Badimon L, Bauersachs J, Baumbach A, Beygui F, Bonaros N, De Carlo M, Deaton C, Dobrev D, Dunning J, Eeckhout E, Gielen S, Hasdai D, Kirchhof P, Luckraz H, Mahrholdt H, Montalescot G, Paparella D, Rastan AJ, Sanmartin M, Sergeant P, Silber S, Tamargo J, ten Berg J, Thiele H, van Geuns RJ, Wagner HO, Wassmann S, Wendler O, Zamorano JL; Task Force on Myocardial Revascularization of the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery; European Association of Percutaneous Cardiovascular Interventions. 2014 ESC/EACTS Guidelines on myocardial revascularization: the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur J Cardiothorac Surg. 2014 Oct;46(4):517-92. doi: 10.1093/ejcts/ezu366. Epub 2014 Aug 29. No abstract available.

    PubMed 25173601

  • Ferreira-Gonzalez I, Marsal JR, Ribera A, Permanyer-Miralda G, Garcia-Del Blanco B, Marti G, Cascant P, Martin-Yuste V, Brugaletta S, Sabate M, Alfonso F, Capote ML, De La Torre JM, Ruiz-Lera M, Sanmiguel D, Cardenas M, Pujol B, Baz JA, Iniguez A, Trillo R, Gonzalez-Bejar O, Casanova J, Sanchez-Gila J, Garcia-Dorado D. Background, incidence, and predictors of antiplatelet therapy discontinuation during the first year after drug-eluting stent implantation. Circulation. 2010 Sep 7;122(10):1017-25. doi: 10.1161/CIRCULATIONAHA.110.938290. Epub 2010 Aug 23.

    PubMed 20733100

  • D'Ascenzo F, Bollati M, Clementi F, Castagno D, Lagerqvist B, de la Torre Hernandez JM, ten Berg JM, Brodie BR, Urban P, Jensen LO, Sardi G, Waksman R, Lasala JM, Schulz S, Stone GW, Airoldi F, Colombo A, Lemesle G, Applegate RJ, Buonamici P, Kirtane AJ, Undas A, Sheiban I, Gaita F, Sangiorgi G, Modena MG, Frati G, Biondi-Zoccai G. Incidence and predictors of coronary stent thrombosis: evidence from an international collaborative meta-analysis including 30 studies, 221,066 patients, and 4276 thromboses. Int J Cardiol. 2013 Jul 31;167(2):575-84. doi: 10.1016/j.ijcard.2012.01.080. Epub 2012 Feb 22.

    PubMed 22360945

  • Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004 Feb 17;109(6):701-5. doi: 10.1161/01.CIR.0000116202.41966.D4. Epub 2004 Jan 26.

    PubMed 14744976

  • Hassan AK, Bergheanu SC, Stijnen T, van der Hoeven BL, Snoep JD, Plevier JW, Schalij MJ, Wouter Jukema J. Late stent malapposition risk is higher after drug-eluting stent compared with bare-metal stent implantation and associates with late stent thrombosis. Eur Heart J. 2010 May;31(10):1172-80. doi: 10.1093/eurheartj/ehn553. Epub 2009 Jan 21.

    PubMed 19158118

  • Lee CW, Kang SJ, Park DW, Lee SH, Kim YH, Kim JJ, Park SW, Mintz GS, Park SJ. Intravascular ultrasound findings in patients with very late stent thrombosis after either drug-eluting or bare-metal stent implantation. J Am Coll Cardiol. 2010 May 4;55(18):1936-42. doi: 10.1016/j.jacc.2009.10.077.

    PubMed 20430265

  • Alfonso F, Dutary J, Paulo M, Gonzalo N, Perez-Vizcayno MJ, Jimenez-Quevedo P, Escaned J, Banuelos C, Hernandez R, Macaya C. Combined use of optical coherence tomography and intravascular ultrasound imaging in patients undergoing coronary interventions for stent thrombosis. Heart. 2012 Aug;98(16):1213-20. doi: 10.1136/heartjnl-2012-302183.

    PubMed 22826559

  • Guagliumi G, Sirbu V, Musumeci G, Gerber R, Biondi-Zoccai G, Ikejima H, Ladich E, Lortkipanidze N, Matiashvili A, Valsecchi O, Virmani R, Stone GW. Examination of the in vivo mechanisms of late drug-eluting stent thrombosis: findings from optical coherence tomography and intravascular ultrasound imaging. JACC Cardiovasc Interv. 2012 Jan;5(1):12-20. doi: 10.1016/j.jcin.2011.09.018.

    PubMed 22230145

  • Cook S, Ladich E, Nakazawa G, Eshtehardi P, Neidhart M, Vogel R, Togni M, Wenaweser P, Billinger M, Seiler C, Gay S, Meier B, Pichler WJ, Juni P, Virmani R, Windecker S. Correlation of intravascular ultrasound findings with histopathological analysis of thrombus aspirates in patients with very late drug-eluting stent thrombosis. Circulation. 2009 Aug 4;120(5):391-9. doi: 10.1161/CIRCULATIONAHA.109.854398. Epub 2009 Jul 20.

    PubMed 19620501

  • Kolandaivelu K, Swaminathan R, Gibson WJ, Kolachalama VB, Nguyen-Ehrenreich KL, Giddings VL, Coleman L, Wong GK, Edelman ER. Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings. Circulation. 2011 Apr 5;123(13):1400-9. doi: 10.1161/CIRCULATIONAHA.110.003210. Epub 2011 Mar 21.

    PubMed 21422389

  • Palmerini T, Biondi-Zoccai G, Della Riva D, Stettler C, Sangiorgi D, D'Ascenzo F, Kimura T, Briguori C, Sabate M, Kim HS, De Waha A, Kedhi E, Smits PC, Kaiser C, Sardella G, Marullo A, Kirtane AJ, Leon MB, Stone GW. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet. 2012 Apr 14;379(9824):1393-402. doi: 10.1016/S0140-6736(12)60324-9. Epub 2012 Mar 23.

    PubMed 22445239

Questions about this trial

What is this clinical trial studying?

A study testing Coroflex® ISAR Drug-eluting stent and Ultimaster® Drug-eluting stent in people with Coronary Artery Disease, run by Hospital Universitari Vall d'Hebron Research Institute at 3 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 7 inclusion and 19 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 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Percentage of early coating on the struts of the Coroflex® ISAR Drug-eluting stent versus Ultimaster® - Drug eluting stent at 3 months OCT after stent implantation. (time frame: 3 months). The study lists 5 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 NCT02785237, which also lists 33 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 3 Jan 2019.

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