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

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04805619

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis	Device: Biomime Morph, a tapered drug eluting stent (DES) with hybrid design	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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 DESThis 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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 7, 2019

Actual Primary Completion Date :

Dec 8, 2021

Actual Study Completion Date :

Dec 8, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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: [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 Outcome Measures

Major adverse cardiac events and Stent Thrombosis [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.
Efficacy secondary endpoints [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.