SUCCESS (선택, 안전, 효능, 건강 경제 및 promS) PTA 연구 (SUCCESS PTA)
Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).
연구 개요
상태
정황
상세 설명
Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).
This study will capture data from the use of the SELUTION SLR according to its approved labelling. Each indication for use will have a specific data sets in addition to generic data sets that are common across all indications.
Patients will be followed for 5 years post-procedure to obtain safety and efficacy data. A health economic analysis will be made comparing data between countries within the study and to published data for existing treatment options. Generic and disease specific Patient Reported Outcome Measures (PROMs) will be used to measure the impact of the intervention on the overall health status of patients.
Imaging data collection for patients whose standard of care includes imaging follow-up will be captured and analysed.
Data will be collected from any subject who receives a CE marked device for treatment of a peripheral (i.e. non-cardiovascular) vascular lesion.
Data analysis will be stratified by lesion location.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Athens, 그리스
- Attikon University Hospital
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Athens, 그리스
- Athens Medical Center
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Pátrai, 그리스
- General University Hospital of Patras
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Tilburg, 네덜란드
- Elisabeth - TweeSteden Ziekenhuis
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Arnsberg, 독일
- Klinikum Hochsauerland
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Bad Krozingen, 독일
- Universitätsklinikum Freiburg
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Buchholz, 독일
- Krankenhaus Buchholz
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Essen, 독일
- Universitätsklinikum Essen
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Flensburg, 독일
- DIAKO Krankenhaus
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Hamburg, 독일
- Medizinisches Versorgungszentrum
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Heidelberg, 독일
- Universitätsklinikum Heidelberg
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Langensteinbach, 독일
- SRH Klinikum Karlsbad - Langensteinbach
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München, 독일
- LMU Klinikum Campus Großhadern
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Tübingen, 독일
- Universitätsklinikum Tübingen
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Weinheim, 독일
- Grn Klinik Weinheim
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Würzburg, 독일
- Universitätsklinikum Würzburg
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Aarau, 스위스
- Kantonsspital Aarau
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Geneva, 스위스
- Hôpitaux Universitaires de Genève (HUG)
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Lucerne, 스위스
- Luzerner Kantonsspital
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Trnava, 슬로바키아
- Trnava University Hospital
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Singapore, 싱가포르
- National University Hospital Singapore (NUHS)
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La Plata, 아르헨티나
- Hospital Italiano La Plata
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Frimley, 영국
- Frimley Park Hospital
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Leicester, 영국
- University Hospitals of Leicester NHS Trust
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London, 영국
- Barts Health NHS Trust (ROYAL HOSPITAL LONDON)
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London, 영국
- Guy's & St Thomas Hospital
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Redhill, 영국
- East Surrey Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subject age is ≥ 18 years
- Subject is able and willing to provide informed consent
- Subject is suitable for treatment with a MedAlliance SELUTION SLR DEB according to the current Instruction for use.
Exclusion Criteria:
- In the opinion of the treating investigator the subject has a life expectancy of less than 12 months
- In the opinion of the treating investigator the subject is unlikely to comply with the study follow-up regime
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: SELUTION SLR™ DEB
Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter. |
This study will capture data from the use of the SELUTION SLR according to its approved labelling. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinically Driven Target Lesion Revascularization
기간: 1 year after treatment
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The primary endpoint will be freedom from Clinically Driven Target Lesion Revascularisation (CD-TLR) at 1-year post-intervention. |
1 year after treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Device Success
기간: At end of procedure
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Successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure. |
At end of procedure
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Procedure success
기간: At end of procedure
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Device success and residual stenosis ≤50% at the end of the procedure. |
At end of procedure
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Clinical success
기간: At discharge after procedure
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Procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion or TLR) prior to discharge. |
At discharge after procedure
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Major Adverse Limb Events (MALE) composite endpoint
기간: At discharge after procedure and 1, 6, 12, 24, 36, 48 and 60 months
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Severe limb ischemia leading to an intervention or major vascular amputation (above the ankle). |
At discharge after procedure and 1, 6, 12, 24, 36, 48 and 60 months
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Major Cardiac Events Major Cardiac Events
기간: At 1, 6, 12, 24, 36,48, 60 months
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MI, Stroke, Cardiovascular death |
At 1, 6, 12, 24, 36,48, 60 months
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Death
기간: At 1, 6, 12, 24, 36, 48, 60 months
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All-cause, cardiac, device related, procedure related |
At 1, 6, 12, 24, 36, 48, 60 months
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TLR
기간: At 1, 6, 12, 24, 36, 48, 60 months
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Number of Target Lesion Revascularizations |
At 1, 6, 12, 24, 36, 48, 60 months
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TVR
기간: At 1, 6, 12, 24, 36, 48, 60 months
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Number of Target Vessel Revascularizations |
At 1, 6, 12, 24, 36, 48, 60 months
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Time to first CD-TLR
기간: up to 60 months
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Time to first Clinically Driven Target Lesion Revascularization |
up to 60 months
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Target limb revascularization
기간: At 1, 6, 12, 24, 36, 48, 60 months
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Number of Target limb revascularizations |
At 1, 6, 12, 24, 36, 48, 60 months
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Thrombosis at the target site
기간: At 1 month
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Number of Thrombosis at the target site |
At 1 month
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Amputation
기간: up to 60 months
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Number of Amputations |
up to 60 months
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Rutherford Classification score
기간: At 6, 12, 24, 36, 48, 60 months
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Change in Rutherford Classification score from baseline (Scale from 0 to 6, higher score means worse outcome. |
At 6, 12, 24, 36, 48, 60 months
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Ankle Brachial Index (ABI)
기간: At 6, 12 months only
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Change in ankle brachial index (ABI) from baseline |
At 6, 12 months only
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Pedal pulse
기간: 6, 12 months only
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Presence of Pedal pulse |
6, 12 months only
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Wound status if applicable
기간: 6, 12 months only
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location, size, infection, status, Wound, Ischemia and Foot Infection (WIfI) classification system score |
6, 12 months only
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Kawarada Classification score
기간: At end of procedure
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Change from baseline to end of procedure to assess change in severity of Pedal Artery Disease |
At end of procedure
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .