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AtherosclerosisTAPER-INCT04805619

Evaluation of the Neointimal Healing by OCT of the Tapered DES Biomime Morph (TAPER-I Study)

A study testing Biomime Morph, a tapered drug eluting stent (DES) with hybrid design in people with Atherosclerosis, run by University of Sao Paulo General Hospital at 1 site in Brazil.

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 long and very long stents, although they represent a greater navigability challenge, especially in tortuous and calcified coronary arteries, they have the advantage of providing shorter procedural time, with less contrast use, less exposure to radiation, lower cost, lower risk of occlusion of lateral branches, as… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atherosclerosis
What is being tested?
Biomime Morph, a tapered drug eluting stent (DES) with hybrid design
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteBrazil
Study dates
7 Nov 2019to 8 Dec 2021
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

  • General clinical criteria
  • Both gender with age ≥ 18 years
  • Clinical indication for a PCI with a DES due to an acute coronary syndrome for unstable angina or non-ST elevation myocardial infarction (NSTEMI), stable angina, or in asymptomatic patients with objective evidence of ischemia.
  • Included patients must have all inclusion criteria and provide written informed consent.
  • Angiographic criteria
  • Lesions with a length ≥ 30 mm, amenable for the treatment with only one stent
  • Up to 2 "de novo" lesions/patients in native vessels
  • Vessel diameter between 2.5 and 4 mm.

Who cannot join

  • General clinical exclusion criteria
  • Previous use of brachytherapy or a stent in the target vessel;
  • Left ventricular ejection fraction <25%;
  • bleeding diathesis;
  • Contraindication to aspirin or P2Y12 inhibitors, heparina or any component of the DES.
  • Creatinine levels > 2.0mg/dl;
Show all 17Show fewer
  • Leucocyte count < 3.500 céls/mm3;
  • Platelet count < 100.000 céls/mm³
  • Pregnancy;
  • Surgical procedure scheduled within the next 6 months, except if DAPT could be maintained;
  • Impossibility to provide written informed consent.
  • Angiographic Criteria
  • Left main disease > 50%;
  • Bifurcation lesions with side branch > 2.0mm in diameter where a stent should be required in the side branch (2-stent technique);
  • Occluded vessel (Thrombolysis in Myocardial Infaction grade 0 /1)
  • Restenosis;
  • Saphenous vein graft and LIMA.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto do Coração - HCFMUSP

    São Paulo, 05403-900

Other trials in Brazil

About this study

The long and very long stents, although they represent a greater navigability challenge, especially in tortuous and calcified coronary arteries, they have the advantage of providing shorter procedural time, with less contrast use, less exposure to radiation, lower cost, lower risk of occlusion of lateral branches, as well as less interference in the local flow. However, in the context of the use of such long stents, as some vessels have a tapering shape, with a progressively smaller diameter in their more distal segments (as is the typical case of the left anterior descending artery), a significant disproportion (mismatch) of vessel size between the proximal and distal landing zone of the stent can be noted. Such disproportion may lead to the underestimation of the proximal reference or overestimation of the distal reference diameter of the vessel, generating an increase of the stress on the vessel wall, with consequent increase in the risk of restenosis. In view of this situation, long or very long stents were developed in a tapered shape, with progressive reduction of their diameter between their proximal and distal portion, respecting the phenomenon of tapering of the coronary artery during the treatment of very long lesions.Some of these stents also have a hybrid design, with closed cells at the ends and open cells in the middle, allowing a more efficient expansion in their middle portion (thus avoiding the dog-boning phenomenon). However, there is still a lack of studies in the literature evaluating whether these DES in a tapered shape and hybrid cells may effectively heal over time, specially with respect to strut covering and strut malapposition. Thus, this is a prospective, single-arm, open-label study, including patients presenting at least one long or very long lesion (≥ 30 mm), who will undergo angioplasty with a tapered DES. The objective is to analyze the neointimal healing as well as other data on the efficacy and safety of the tapered DES Biomime Morph in patients with long or very long lesions.

Conditions
Atherosclerosis
Being tested
Biomime Morph, a tapered drug eluting stent (DES) with hybrid design
Keywords
Atherosclerosis, Stent, Long coronary lesions, Angioplasty, Neointimal healing, Tapering
Medical subject headings
Atherosclerosis

What participants receive

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

  • Biomime Morph, a tapered drug eluting stent (DES) with hybrid designDevice

    Also called Stent

    Biomime Morph DES is a cobalt-chromium stent, with strut thickness of 65 µm, a hybrid cell design (closed cells in the extremity and open cells in the middle) and a conic shape, where the proximal part of the stent is 0.5 mm larger than the distal part (Table 1). In addition, the Biomime Morph elutes Sirolimus from a biodegradable polymer matrix.

Study groups in NCT04805619
Study groupRoleWhat they receive
Arm 1ExperimentalPatients with long or very long lesions (≥ 30 mm) in native coronary arteries.
Receives: Device: Biomime Morph, a tapered drug eluting stent (DES) with hybrid design

What is being measured

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

  1. The primary endpoint is the stent coverage and neo-intimal growth assessed at six months. The neointimal healing score is based on four scaffold- or stent-related characteristics and is calculated on a lesion level:

    1. Presence of filling defect (% intraluminal defect, ILD) is assigned a weight of "4"
    2. Presence of both malapposed and uncovered struts (% malapposed/uncovered, MU) is assigned a weight of "3"
    3. Presence of uncovered struts alone (% malapposed, M) is assigned a weight of "2"
    4. Presence of malapposed struts alone (% uncovered, U) is assigned a weight of "1" Neointimal healing score = (%ILD * 4)+(%MU * 3)+(%U * 2)+(%M * 1).

    Measured: Six months

Secondary outcomes (2)

  1. Major adverse cardiac events and Stent Thrombosis

    • Major adverse cardiac events (MACE), defined as a composite of death, nonfatal myocardial infarct or target vessel revascularization, at 30 days, 6 months and 1 year.
    • Stent thrombosis at 1 year.

    Measured: 30 days, 6 months and 1 year

  2. Efficacy secondary endpoints

    • Angiographic success
    • Procedure success
    • Target lesion revascularization (TLR) at 6 and 12 months
    • Target vessel revascularization (TVR) at 6 and 12 months
    • Modified neointimal healing score, calculated at 6 months
    • Intra-segment luminal loss (intra-stent segment and proximal and distal 5 mm edges) at 6 months
    • Intra-stent luminal loss at 6 months
    • Intra-stent and intra-segment binary restenosis
    • Percentage of neointimal obstruction
    • Intra-stent mean percentage neointimal obstruction by the optical frequency domain image (OFDI)

    Measured: 6 months and 12 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 Mar 2021
  2. Study start7 Nov 2019
  3. Primary completion8 Dec 2021
  4. Study completion8 Dec 2021

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
Not applicable
Intervention model
Single group
Model description
This is a prospective, single-arm, open-label study, including patients presenting at least one long or very long lesion (≥ 30 mm), who will undergo angioplasty with a tapered DES
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04805619
Sponsor's protocol ID
Instituto do Coração
Acronym
TAPER-I
Status last verified
May 2022
First submitted
12 Mar 2021
Last updated
25 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Berry D. The unlocking of the coronary arteries: origins of angioplasty. A short historical review of arterial dilatation from Dotter to the creative Gruentzig. Eur Heart J. 2009 Jun;30(12):1421-2. doi: 10.1093/eurheartj/ehp182. No abstract available.

    PubMed 19525552

  • Honda Y, Muramatsu T, Ito Y, Sakai T, Hirano K, Yamawaki M, Araki M, Kobayashi N, Takimura H, Sakamoto Y, Mouri S, Tsutumi M, Takama T, Takafuji H, Tokuda T, Makino K. Impact of ultra-long second-generation drug-eluting stent implantation. Catheter Cardiovasc Interv. 2016 Feb 1;87(2):E44-53. doi: 10.1002/ccd.26010. Epub 2015 May 23.

    PubMed 26010548

  • Bouras G, Jhamnani S, Ng VG, Haimi I, Mao V, Deible R, Cao S, Sudhir K, Lansky AJ. Clinical outcomes after PCI treatment of very long lesions with the XIENCE V everolimus eluting stent; Pooled analysis from the SPIRIT and XIENCE V USA prospective multicenter trials. Catheter Cardiovasc Interv. 2017 May;89(6):984-991. doi: 10.1002/ccd.26711. Epub 2016 Aug 22.

    PubMed 27545721

  • Sgueglia GA, Belloni F, Summaria F, Conte M, Cortese B, Silva PL, Ricci R, Lioy E, Pucci E, Gaspardone A. One-year follow-up of patients treated with new-generation polymer-based 38 mm everolimus-eluting stent: the P38 study. Catheter Cardiovasc Interv. 2015 Feb 1;85(2):218-24. doi: 10.1002/ccd.25542. Epub 2014 May 26.

    PubMed 24824088

  • Meier B, Gruentzig AR, Hollman J, Ischinger T, Bradford JM. Does length or eccentricity of coronary stenoses influence the outcome of transluminal dilatation? Circulation. 1983 Mar;67(3):497-9. doi: 10.1161/01.cir.67.3.497.

    PubMed 6217920

  • Kornowski R, Bhargava B, Fuchs S, Lansky AJ, Satler LF, Pichard AD, Hong MK, Kent KM, Mehran R, Stone GW, Leon MB. Procedural results and late clinical outcomes after percutaneous interventions using long (> or = 25 mm) versus short (< 20 mm) stents. J Am Coll Cardiol. 2000 Mar 1;35(3):612-8. doi: 10.1016/s0735-1097(99)00580-x.

    PubMed 10716462

  • Schalij MJ, Udayachalerm W, Oemrawsingh P, Jukema JW, Reiber JH, Bruschke AV. Stenting of long coronary artery lesions: initial angiographic results and 6-month clinical outcome of the micro stent II-XL. Catheter Cardiovasc Interv. 1999 Sep;48(1):105-12. doi: 10.1002/(sici)1522-726x(199909)48:13.0.co;2-0.

    PubMed 10467083

  • Kobayashi Y, De Gregorio J, Kobayashi N, Akiyama T, Reimers B, Finci L, Di Mario C, Colombo A. Stented segment length as an independent predictor of restenosis. J Am Coll Cardiol. 1999 Sep;34(3):651-9. doi: 10.1016/s0735-1097(99)00303-4.

    PubMed 10483943

  • Kobayashi Y, De Gregorio J, Kobayashi N, Reimers B, Albiero R, Vaghetti M, Finci L, Di Mario C, Colombo A. Comparison of immediate and follow-up results of the short and long NIR stent with the Palmaz-Schatz stent. Am J Cardiol. 1999 Sep 1;84(5):499-504. doi: 10.1016/s0002-9149(99)00366-5.

    PubMed 10482144

  • Di Sciascio G, Patti G, Nasso G, Manzoli A, D'Ambrosio A, Abbate A. Early and long-term results of stenting of diffuse coronary artery disease. Am J Cardiol. 2000 Dec 1;86(11):1166-70. doi: 10.1016/s0002-9149(00)01197-8.

    PubMed 11090785

  • Kastrati A, Elezi S, Dirschinger J, Hadamitzky M, Neumann FJ, Schomig A. Influence of lesion length on restenosis after coronary stent placement. Am J Cardiol. 1999 Jun 15;83(12):1617-22. doi: 10.1016/s0002-9149(99)00165-4.

    PubMed 10392864

  • Saucedo JF, Kennard ED, Popma JJ, Talley D, Lansky A, Leon MB, Baim DS. Importance of lesion length on new device angioplasty of native coronary arteries. NACI Investigators. New Approaches to Coronary Interventions. Catheter Cardiovasc Interv. 2000 May;50(1):19-25. doi: 10.1002/(sici)1522-726x(200005)50:13.0.co;2-h.

    PubMed 10816274

  • Kornowski R, Mehran R, Hong MK, Satler LF, Pichard AD, Kent KM, Mintz GS, Waksman R, Laird JR, Lansky AJ, Bucher TA, Popma JJ, Leon MB. Procedural results and late clinical outcomes after placement of three or more stents in single coronary lesions. Circulation. 1998 Apr 14;97(14):1355-61. doi: 10.1161/01.cir.97.14.1355.

    PubMed 9577946

  • Applegate RJ, Sacrinty MT, Kutcher MA, Santos RM, Gandhi SK, Little WC. Effect of length and diameter of drug-eluting stents versus bare-metal stents on late outcomes. Circ Cardiovasc Interv. 2009 Feb;2(1):35-42. doi: 10.1161/CIRCINTERVENTIONS.108.805630. Epub 2009 Feb 10.

    PubMed 20031691

  • Shirai S, Kimura T, Nobuyoshi M, Morimoto T, Ando K, Soga Y, Yamaji K, Kondo K, Sakai K, Arita T, Goya M, Iwabuchi M, Yokoi H, Nosaka H, Mitsudo K; j-Cypher Registry Investigators. Impact of multiple and long sirolimus-eluting stent implantation on 3-year clinical outcomes in the j-Cypher Registry. JACC Cardiovasc Interv. 2010 Feb;3(2):180-8. doi: 10.1016/j.jcin.2009.11.009.

    PubMed 20170875

Questions about this trial

What is this clinical trial studying?

A study testing Biomime Morph, a tapered drug eluting stent (DES) with hybrid design in people with Atherosclerosis, run by University of Sao Paulo General Hospital at 1 site in Brazil.

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 8 inclusion and 17 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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. 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?

The primary endpoint is the stent coverage and neo-intimal growth assessed at six months. The neointimal healing score is based on four scaffold- or stent-related characteristics and is calculated on a lesion level: (time frame: Six months). 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 NCT04805619, which also lists 26 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 25 May 2022.

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