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

May 24, 2022 updated by: Henrique Barbosa Ribeiro, University of Sao Paulo General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-900
        • Instituto do Coração - HCFMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Patients with long or very long lesions (≥ 30 mm) in native coronary arteries.
Device: Biomime Morph, a tapered drug eluting stent (DES) with hybrid design
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
  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).
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days, 6 months and 1 year
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)
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2019

Primary Completion (Actual)

December 8, 2021

Study Completion (Actual)

December 8, 2021

Study Registration Dates

First Submitted

March 12, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Instituto do Coração

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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