Test of Long-Term Safety and Efficacy of Sirolimus-Permanent-Polymer Eluting Stent (Cypher)- and Sirolimus-Polymer-free Eluting Stents (PPS/PFS) Assessed by Optical Coherence Tomography (PPS/PFS-OCT)
Pilop Trial of OCT-determined Coverage of Permanent or Polymer-free Sirolimus Eluting Stent at Long Term
연구 개요
상태
정황
상세 설명
The mid-term efficacy of drug-eluting stents has been well-established, but there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with permanent polymer-based DES. The extent of strut coverage with reduction of exposed thrombogenic material has been shown to be associated with the inflammatory reaction grade and with the incidence of stent thrombosis. The optical coherence tomography (OCT) is an intravascular imaging modality based on light. The principle is similar to intravascular ultrasound, but due to the much shorter wave length of light, it offers a much better resolution up to 10µm, enabling the exact determination of strut coverage, neointimal thickness, vessel size, presence of dissections, and even the presence of inflammation.
Patients who received a polymer-free or a permanent-polymer sirolimus-eluting stent about 5 years ago without in-segment intervention since, will be evaluated by OCT regarding the healing pattern and the late lumen loss of the stent.
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 장소
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Bavaria
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Munich, Bavaria, 독일, 81675
- 모병
- Klinikum rechts der Isar
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연락하다:
- Steffen Massberg, MD
- 전화번호: 4025 +49 89 12 18
- 이메일: massberg@dhm.mhn.de
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Munich, Bavaria, 독일, 80636
- 모병
- Deutsches Herzzentrum Muenchen
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연락하다:
- Julinda Mehilli, MD
- 전화번호: 4582 +49 89 12 18
- 이메일: mehilli@dhm.mhn.de
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연락하다:
- Klaus Tiroch, MD
- 전화번호: 4578 +49 89 12 18
- 이메일: tiroch@dhm.mhn.de
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients older than age 18 with with previous implantation of polymer-free or permanent-polymer sirolimus-eluting stents 5 years ago due to ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels.
- Written, informed consent by the patient or her/his legally-authorized representative for participation in the study and assessment by OCT.
- In women with childbearing potential a negative pregnancy test is mandatory.
Exclusion Criteria:
- Intervention in the segment of the study stent after the index procedure
- Target lesion located in the left main trunk.
- In-stent restenosis with difficulty to pass the OCT device
- Acute myocardial infarction
- Known allergy to the study medications: Sirolimus, rapamycin, probucol or stainless steel.
- Pregnancy (present, suspected or planned) or positive pregnancy test.
- Patient's inability to fully cooperate with the study protocol.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Arm 1
Sirolimus-Permanent-Polymer Eluting Stent
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due randomization sirolimus-permanent-polymer eluting stent was implanted
다른 이름들:
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활성 비교기: Arm 2
Sirolimus-Polymer-free Eluting Stent
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due randomization sirolimus-polymer-free eluting stent was implanted
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Degree of stent strut coverage after 5 years assessed by OCT for each visible strut segment
기간: 5 years
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5 years
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Percentage of malapposed strut assessed by OCT
기간: 5 years
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5 years
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Percentage of uncovered malapposed struts assessed by OCT
기간: 5 years
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5 years
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Morphologic differences of neointima between stents
기간: 5 years
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5 years
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Late lumen loss at 5 years assessed by OCT
기간: 5 years
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5 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Klaus Tiroch, MD, Deutsches Herzzentrum Muenchen
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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
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