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Coronary Artery DiseasePhase 4VISTANCT03026465

Vessel Injury in Relation With Strut Thickness Assessed by OCT

A Phase 4 study testing Polymer-free stent and Biodegradable-polymer stent in people with Coronary Artery Disease, run by Fundacion Investigacion Interhospitalaria Cardiovascular 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 present study is to determine the relation between vascular injury induced by the stent and strut thickness. 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?
Polymer-free stent and Biodegradable-polymer stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesSpain
Study dates
16 Feb 2017to 27 Jul 2018
Phase
Phase 4
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

  • Patients older than 18 years
  • Ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of >50% de novo stenosis located in native coronary vessels

Who cannot join

  • Target lesion located in the left main stem
  • STEMI
  • Restenosis
  • Cardiogenic shock
  • Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol noncompliance
  • Known allergy to the study medications (probucol, sirolimus, zotarolimus)
  • Pregnancy (present, suspected, or planned)

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario de La Princesa

    Madrid

  • Complejo Hospitalario Universitario de Vigo

    Vigo, Pontevedra

Other trials in Spain

About this study

Official title: Vessel Injury in Relation With Strut Thickness Assessed by OCT (VISTA): A Comparison of Vascular Injury Induced by a Polymer Free Sirolimus and Probucol Eluting Stent and a Biodegradable-polymer Biolimus-eluting Stent

The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness.

Read the detailed description

Thinner struts produce less arterial injury after stent implantation.The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness. Vessel injury after stent implantation will be evaluated with optical coherence tomography (OCT). Two stents platforms with different strut thickness (Coroflex ISAR 50 microns and Biomatrix 120 microns) will be compared.

Being tested
Polymer-free stent, Biodegradable-polymer stent
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.

  • Polymer-free stentDevice

    Also called Coroflex ISAR

    PCI using a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR)

  • Biodegradable-polymer stentDevice

    Also called Biomatrix

    PCI using a biodegradable-polymer biolimus-eluting stent (Biomatrix)

Study groups in NCT03026465
Study groupRoleWhat they receive
Coroflex ISAR stentExperimentalPCI with a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR stent) with very thin struts (50 µm). During the PCI, an OCT assessment (baseline and post-implantation) will be performed.
Receives: Device: Polymer-free stent
Biomatrix stentActive comparatorPCI with a biodegradable-polymer biolimus-eluting stent (Biomatrix stent) with 120 µm struts. During the PCI, an OCT assessment (baseline and post-implantation) will be performed.
Receives: Device: Biodegradable-polymer stent

What is being measured

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

  1. OCT-based intimal injury score

    OCT-based intimal injury score estimated after implantation of the Coroflex-ISAR and Biomatrix DES

    Measured: Up to 1 day (evaluated after stent implantation)

Secondary outcomes (5)

  1. Tissue prolapse area

    Tissue prolapse area assessed by OCT after implantation of Coroflex-ISAR and Biomatrix will be measured

    Measured: Up to 1 day (evaluated after stent implantation)

  2. Incidence of stent malapposition

    Stent apposition after implantation of Coroflex-ISAR and Biomatrix as assessed by OCT

    Measured: Up to 1 day (evaluated after stent implantation)

  3. Incidence of stent underexpansion

    Stent expansion will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix

    Measured: Up to 1 day (evaluated after stent implantation)

  4. Stent symmetry after implantation

    Stent symmetry will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix

    Measured: Up to 1 day (evaluated after stent implantation)

  5. Baseline plaque type

    Baseline plaque type will be assessed by OCT (fibrous, fibrocalcific or lipid-rich)

    Measured: Up to 1 day (evaluated after stent implantation)

Timeline

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

  1. First posted20 Jan 2017 (estimated)
  2. Study start16 Feb 2017
  3. Primary completion27 Jul 2018
  4. Study completion27 Jul 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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03026465
Sponsor's protocol ID
VISTA
Acronym
VISTA
Status last verified
Aug 2019
First submitted
28 Oct 2016
Last updated
21 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sullivan TM, Ainsworth SD, Langan EM, Taylor S, Snyder B, Cull D, Youkey J, Laberge M. Effect of endovascular stent strut geometry on vascular injury, myointimal hyperplasia, and restenosis. J Vasc Surg. 2002 Jul;36(1):143-9. doi: 10.1067/mva.2002.122878.

    PubMed 12096272

  • Hara H, Nakamura M, Palmaz JC, Schwartz RS. Role of stent design and coatings on restenosis and thrombosis. Adv Drug Deliv Rev. 2006 Jun 3;58(3):377-86. doi: 10.1016/j.addr.2006.01.022. Epub 2006 Mar 6.

    PubMed 16650911

  • Farb A, Weber DK, Kolodgie FD, Burke AP, Virmani R. Morphological predictors of restenosis after coronary stenting in humans. Circulation. 2002 Jun 25;105(25):2974-80. doi: 10.1161/01.cir.0000019071.72887.bd.

    PubMed 12081990

  • Rogers C, Edelman ER. Endovascular stent design dictates experimental restenosis and thrombosis. Circulation. 1995 Jun 15;91(12):2995-3001. doi: 10.1161/01.cir.91.12.2995.

    PubMed 7796511

  • Scott NA. Restenosis following implantation of bare metal coronary stents: pathophysiology and pathways involved in the vascular response to injury. Adv Drug Deliv Rev. 2006 Jun 3;58(3):358-76. doi: 10.1016/j.addr.2006.01.015. Epub 2006 Mar 6.

    PubMed 16733073

  • Foin N, Lee RD, Torii R, Guitierrez-Chico JL, Mattesini A, Nijjer S, Sen S, Petraco R, Davies JE, Di Mario C, Joner M, Virmani R, Wong P. Impact of stent strut design in metallic stents and biodegradable scaffolds. Int J Cardiol. 2014 Dec 20;177(3):800-8. doi: 10.1016/j.ijcard.2014.09.143. Epub 2014 Oct 7.

    PubMed 25449502

  • 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

  • Foin N, Gutierrez-Chico JL, Nakatani S, Torii R, Bourantas CV, Sen S, Nijjer S, Petraco R, Kousera C, Ghione M, Onuma Y, Garcia-Garcia HM, Francis DP, Wong P, Di Mario C, Davies JE, Serruys PW. Incomplete stent apposition causes high shear flow disturbances and delay in neointimal coverage as a function of strut to wall detachment distance: implications for the management of incomplete stent apposition. Circ Cardiovasc Interv. 2014 Apr;7(2):180-9. doi: 10.1161/CIRCINTERVENTIONS.113.000931. Epub 2014 Mar 18.

    PubMed 24642998

  • Bourantas CV, Papafaklis MI, Kotsia A, Farooq V, Muramatsu T, Gomez-Lara J, Zhang YJ, Iqbal J, Kalatzis FG, Naka KK, Fotiadis DI, Dorange C, Wang J, Rapoza R, Garcia-Garcia HM, Onuma Y, Michalis LK, Serruys PW. Effect of the endothelial shear stress patterns on neointimal proliferation following drug-eluting bioresorbable vascular scaffold implantation: an optical coherence tomography study. JACC Cardiovasc Interv. 2014 Mar;7(3):315-24. doi: 10.1016/j.jcin.2013.05.034. Epub 2014 Feb 13.

    PubMed 24529931

  • Kastrati A, Mehilli J, Dirschinger J, Dotzer F, Schuhlen H, Neumann FJ, Fleckenstein M, Pfafferott C, Seyfarth M, Schomig A. [Intracoronary Stenting and Angiographic Results Strut Thickness Effect on Restenosis Outcome (ISAR-STEREO) Trial]. Vestn Rentgenol Radiol. 2012 Mar-Apr;(2):52-60. Russian.

    PubMed 22730760

  • Pache J, Kastrati A, Mehilli J, Schuhlen H, Dotzer F, Hausleiter J, Fleckenstein M, Neumann FJ, Sattelberger U, Schmitt C, Muller M, Dirschinger J, Schomig A. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial. J Am Coll Cardiol. 2003 Apr 16;41(8):1283-8. doi: 10.1016/s0735-1097(03)00119-0.

    PubMed 12706922

  • Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 Jul 4;48(1):193-202. doi: 10.1016/j.jacc.2006.03.042. Epub 2006 May 5.

    PubMed 16814667

  • Koppara T, Joner M, Bayer G, Steigerwald K, Diener T, Wittchow E. Histopathological comparison of biodegradable polymer and permanent polymer based sirolimus eluting stents in a porcine model of coronary stent implantation. Thromb Haemost. 2012 Jun;107(6):1161-71. doi: 10.1160/TH12-01-0043. Epub 2012 Apr 26.

    PubMed 22535188

  • 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.

    PubMed 17438147

  • Joner M, Nakazawa G, Finn AV, Quee SC, Coleman L, Acampado E, Wilson PS, Skorija K, Cheng Q, Xu X, Gold HK, Kolodgie FD, Virmani R. Endothelial cell recovery between comparator polymer-based drug-eluting stents. J Am Coll Cardiol. 2008 Jul 29;52(5):333-42. doi: 10.1016/j.jacc.2008.04.030.

    PubMed 18652940

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Polymer-free stent and Biodegradable-polymer stent in people with Coronary Artery Disease, run by Fundacion Investigacion Interhospitalaria Cardiovascular 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 2 inclusion and 7 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 21 Aug 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

OCT-based intimal injury score (time frame: Up to 1 day (evaluated after stent implantation)). 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 NCT03026465, which also lists 25 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 21 Aug 2019.

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