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Completed

NCT Number: NCT04805619

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

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto do Coração - HCFMUSP

São Paulo, 05403-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

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

Device

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.

Other names: Stent

Primary outcomes

  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:

    Time frame: Six months

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

Secondary outcomes

  1. Major adverse cardiac events and Stent Thrombosis

    Time frame: 30 days, 6 months and 1 year

    • 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.

  2. Efficacy secondary endpoints

    Time frame: 6 months and 12 months

    • 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)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Acronym: TAPER-I

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2021
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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