Clinical trial NCT01375855: Late Incomplete Stent Apposition Evaluation II: Comparison Between Polimer-based and No-polimer Stent System. IVUS Based Study
Official title: Late Incomplete Stent Apposition Evaluation II: Vascular Effects Evaluation After Polimer and No-polimer Based Coronary Artery Drug Eluting Stent Ilmplantation. An IVUS Based Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Late stent malapposition
stent thrombosis
IVUS
non-polimeric stent
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2011-06-17
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vascular effects evaluation after non-polimeric and polimeric paclitaxel stent implantation.In particular the investigators will use Taxus )as a polimeric stent)and Axxion (as a non-polimeirc)stent system. The investigators will look at late stent malapposition by means of intracoronary ultrasound imaging technique (IVUS) at baseline and 9 months follow-up. The investigators sought to compare the two stent types with the same drug to verify the polimer role. The polimer itself seems to provoke inflammation and hypersensibility if the arterial wall and it seems to be the base of a process of positive remodeling found at drug eluting stent implantation site.

This positive remodeling is the mechanism producing late stent malapposition which on its turn can determine stent thrombosis, as demonstrated by pathological studies. At the same time the investigators will study the incidence of clinical events like myocardial infarction, stent thrombosis, TLR and death along with the incidence of angiographic restenosis at 2 years follow up.


Eligibility criteria: Inclusion Criteria:

* Patients with coronary artery stenosis in one, two or three vessels, and with objective evidence of isquemia.
* The stenosis must allow IVUS analisis, must be treatable with angioplasty with stent
* Target Vessel diameter must be between 2.25- 4 mm with QCA.
* Patients must sign informed consent
* Patients and their physician must accept the angiographic follow-up

Exclusion Criteria:

* 18 years old patients
* SCA within the last 72 hours, or patients with CK twice over the upper normal limit
* Pregnancy
* Target vessel diameter \< 2.25 or \> 4 mm by QCA
* Previous brakitherapy or DES in the target lesion
* Restenotic lesion
* -Allergy to aspirin, clopidogrel or ticlopidin
* Patients enrolled in other studies or trials
* By-pass graft lesions
* Real bifurcationa lesions
* Severe Renal insufficiency (creatinin clearance \< 30 ml/min).
* Severe Liver failure(GOT y GPT \> 3 times the upper normal limit)
* Life expectancy \< 1 year because of other pathologies

Primary outcomes:
measure: Intra coronary ultrasound analysis to verify stent malapposition at follow-up
timeFrame: 9 months
Secondary outcomes:
measure: Clinical events (myocardial infarction, TLR,at 1, 9, 12, 24 months follow-up:; Incidence of restenosis with QCA at 9 months follow-up Intimal hiperplasia measured by IVUS at 9 months follow-up; Stent Thrombosis.
timeFrame: 9 months and 2 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu y Sant Pau
Study officials:
affiliation: Hospital de la Santa Creu Y Sant Pau, Unidad de Hemodinamica
name: Manel Sabate, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong MK, Mintz GS, Lee CW, Park DW, Lee SW, Kim YH, Kang DH, Cheong SS, Song JK, Kim JJ, Park SW, Park SJ. Impact of late drug-eluting stent malapposition on 3-year clinical events. J Am Coll Cardiol. 2007 Oct 9;50(15):1515-6. doi: 10.1016/j.jacc.2007.07.038. Epub 2007 Aug 27. No abstract available.
citation: Shiratori Y, Cola C, Brugaletta S, Alvarez-Contreras L, Martin-Yuste V, del Blanco BG, Ruiz-Salmeron R, Diaz J, Pinar E, Marti V, Garcia-Picart J, Sabate M. Randomized comparison between polymer-free versus polymer-based paclitaxel-eluting stent: two-year final clinical results. Circ Cardiovasc Interv. 2014 Jun;7(3):312-21. doi: 10.1161/CIRCINTERVENTIONS.113.000800. Epub 2014 May 6.