- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01375855
Late Incomplete Stent Apposition Evaluation II: Comparison Between Polimer-based and No-polimer Stent System. IVUS Based Study (LISAII)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Manel sabate, MD, PhD
- Phone Number: 0034935565851
- Email: msabatet@santpau.es
Study Contact Backup
- Name: Clarissa Cola, MD
- Phone Number: 0034935565851
- Email: clarissacola@gmail.com
Study Locations
-
-
-
Barcelona, Spain, 08025
- Recruiting
- Hospital de la Santa Creu y Sant Pau
-
Principal Investigator:
- Manel Sabate, MD, PhD
-
Contact:
- Manel sabate, MD, PhD
- Phone Number: 0034935565851
- Email: msabatet@santpau.es
-
Contact:
- Clarissa Cola, MD
- Phone Number: 0034935565851
- Email: clarissacola@gmail.com
-
Sub-Investigator:
- Victoria Martin Yuste, MD
-
Sub-Investigator:
- Clarissa Cola, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Polimeric-PES
Arm receiving polimeric stent (Taxus)
|
Coronary artery stent implantation
|
Active Comparator: Non-Polimeric PES
Arm receiving non-polimeric PES (axxion)
|
Coronary artery stent implantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intra coronary ultrasound analysis to verify stent malapposition at follow-up
Time Frame: 9 months
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 9 months and 2 years
|
9 months and 2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Manel Sabate, MD, PhD, Hospital de la Santa Creu Y Sant Pau, Unidad de Hemodinamica
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-000142-12
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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