Atherosclerosis
Conditions
Keywords
Atherosclerosis, Stent, Long coronary lesions, Angioplasty, Neointimal healing, Tapering
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.
Interventions
DEVICEBiomime 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.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 DES
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Brazil
Outcome results
None listed