Clinical trial NCT04805619: Evaluation of the Neointimal Healing by OCT of the Tapered DES Biomime Morph (TAPER-I Study)
Official title: Evaluation of the Neointimal Healing by OCT of the Tapered DES Biomime Morph (TAPER-I Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Keywords: Atherosclerosis
Stent
Long coronary lesions
Angioplasty
Neointimal healing
Tapering
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
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:
timeFrame: Six months
Secondary outcomes:
measure: Major adverse cardiac events and Stent Thrombosis
timeFrame: 30 days, 6 months and 1 year
measure: Efficacy secondary endpoints
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração - HCFMUSP
Study officials:
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