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.
연구 개요
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 장소
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Barcelona, 스페인, 08025
- 모병
- Hospital de La Santa Creu Y Sant Pau
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수석 연구원:
- Manel Sabate, MD, PhD
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연락하다:
- Manel sabate, MD, PhD
- 전화번호: 0034935565851
- 이메일: msabatet@santpau.es
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연락하다:
- Clarissa Cola, MD
- 전화번호: 0034935565851
- 이메일: clarissacola@gmail.com
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부수사관:
- Victoria Martin Yuste, MD
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부수사관:
- Clarissa Cola, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Polimeric-PES
Arm receiving polimeric stent (Taxus)
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Coronary artery stent implantation
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활성 비교기: Non-Polimeric PES
Arm receiving non-polimeric PES (axxion)
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Coronary artery stent implantation
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Intra coronary ultrasound analysis to verify stent malapposition at follow-up
기간: 9 months
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9 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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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.
기간: 9 months and 2 years
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9 months and 2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Manel Sabate, MD, PhD, Hospital de la Santa Creu Y Sant Pau, Unidad de Hemodinamica
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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