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대동맥-장골 폐쇄성 질환 치료를 위한 iCover Covered 스텐트의 안전성 및 유효성 평가 (iliCo)

2026년 11월 3일 업데이트: iVascular S.L.U.

대동맥 장골 폐색 질환 치료를 위한 iCover 적용 스텐트의 안전성과 유효성을 평가하기 위한 전향적, 다기관, 비무작위, 단일 암 관찰 연구

The objective of this prospective, multi-center, non-randomized, single-arm observational study is to evaluate the safety and the efficacy of the iCover covered stent over a 24-month follow-up period for the treatment of de novo iliac occlusive lesions, defined by a significant vessel stenosis ≥70%, in patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5).

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

This is a prospective, single-arm, multinational, and multicenter study conducted to evaluate the safety and efficacy of the iCover covered stent for the treatment of de novo iliac occlusive lesions (common and/or external iliac arteries) in patients with symptomatic lower limb arteriopathy. The primary endpoint of the study is primary patency, defined as the absence of restenosis in the target lesion over a 12-month follow-up period in patients who did not undergo a reintervention on the target lesion. Restenosis is defined as a reduction in the luminal diameter of more than 50%, assessed either by duplex ultrasound (considered as a peak systolic velocity index ≥ 2.4 at the target lesion) or by angio-CT (multiplanar reconstruction). Secondary endpoints include: technical and procedural success rate, freedom from all major adverse events, incidence of procedure- or device-related major local complications at the treated lesion, rate of SAEs, major amputation rate at the target limb, primary sustained clinical improvement (improvement in Rutherford classification), primary and secondary patency rates, TLR and TVR rates, and changes in ABI, the Walking Impairment Questionnaire, and the EQ-5D questionnaire from baseline.

연구 유형

관찰

등록 (실제)

241

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 독일
      • Berlin, 독일
        • KEH Berlin
      • Rendsburg, 독일
        • Imland Klinik Rendsburg
    • Baden-Wurttemberg
      • Bad Krozingen, Baden-Wurttemberg, 독일, 79189
        • Herzzentrum Bad Krozingen
    • Rhineland-Palatinate
      • Kaiserslautern, Rhineland-Palatinate, 독일, 67657
        • MVZ Kaiserslautern
    • Saxony
      • Leipzig, Saxony, 독일, 04103
        • Universitätsklinikum Leipzig
  • 벨기에
      • Aalst, 벨기에
        • Onze Lieve Vrouw Aalst
      • Bonheiden, 벨기에
        • Imelda Bonheiden
      • Dendermonde, 벨기에
        • Az Sint Blasius Dendermonde
      • Genk, 벨기에
        • ZOL Genk
  • 스페인
      • Barcelona, 스페인
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, 스페인
        • Hospital de Santa Creu i Sant Pau
      • Bilbao, 스페인
        • Hospital de Cruces
      • Sabadell, 스페인
        • Hospital Parc Taulí
  • 프랑스
      • Brest, 프랑스
        • Centre Hospitalier Universitaire de Brest
      • Paris, 프랑스
        • Hôpital Paris Saint Joseph
      • Paris, 프랑스
        • CHU Pitié Salpêtrière
      • Pessac, 프랑스
        • Hôpital privé Saint-Martin
      • Villeneuve-d'Ascq, 프랑스
        • Hôpital privé Villeneuve d'Ascq

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5). Patients with de novo atheromatous aorto-iliac lesions.

According to the incidence of TASC II lesions, approximately 70% of the patients will be classified as TASC II A or B lesions, while the other 30% will be classified as TASC II C or D lesions.

설명

Inclusion criteria

  1. ≥ 18 years of age
  2. Rutherford clinical stage 2 to 5
  3. Significant (≥70%) stenosis of atheromatous iliac lesions evidenced by duplex scan, MRI CT angiography or arteriography
  4. De novo atheromatous lesion of the aortoiliac segment
  5. Patient informed about the study and collection of the patient's informed consent agreement Exclusion criteria

Subjects will not be eligible to participate in the study if any of the following conditions are present in the subject:

  1. Protected adult patients, guardianship, curatorship, safeguard of justice
  2. Woman with possibility of pregnancy
  3. Patient with asymptomatic atheromatous lesions
  4. Patient with inflow lesion in the infrarenal aorta
  5. Patient treated with Covered endovascular reconstruction of aortic bifurcation (CERAB reconstruction)
  6. Acute ischemia or acute thrombosis
  7. Non-atherosclerotic disease
  8. History of coagulopathy
  9. Severe comorbidities with life expectancy <2 years
  10. Contraindication to taking antiplatelet aggregation therapy (aspirin or clopidogrel). The patient must be able to take an antiplatelet aggregation for at least 3 months after the procedure
  11. Patient participating in another clinical study which may interfere with the results
  12. Comorbidity or any reason which, according to the investigator, could limit the participation, the patient's adherence with the follow-up or the scientific integrity of the study
  13. Lesion near or adjacent to an aneurysm
  14. Inability to follow-up during the investigation
  15. Patient objection to participate in the investigation

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: COHORT
  • 시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트
개입 / 치료
iCover covered stent

Percutaneous transluminal angioplasty (PTA)
장치: Covered stent implantation

Percutaneous transluminal angioplasty (PTA) with iCover covered stent for the treatment of de novo aorto-iliac occlusive lesions

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Primary Patency
기간: 12 months after index procedure.

The primary patency, defined as the absence of restenosis in the target lesion over the 12-month follow-up period in patients who did not undergo a reintervention on the target lesion.
12 months after index procedure.

2차 결과 측정

결과 측정
측정값 설명
기간
Technical success rate
기간: Day 0.

Technical success rate, defined as the ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30% after iCover stent graft insertion. Outcomes will be computed as the percentage of lesions treated at the end of the procedure.
Day 0.
Procedural success rate
기간: Day 0.

Procedural success rate, defined as technical success and no complications during the procedure including general and local complications as defined in the protocol. Outcomes will be computed as the percentage of patients at the end of the procedure.
Day 0.
Freedom from All Major Adverse Event (MAEs)
기간: 1, 6, 12, 24 months after index procedure.

MAEs are described as All-Cause Mortality post-procedure, Target Lesion Revascularization (TLR) post-procedure and Major Amputation of the Target Limb post-procedure (amputations above the ankle of the target leg).
1, 6, 12, 24 months after index procedure.
Incidence of Procedure- or Device- related Major Local Complications
기간: Up to 30 days after index procedure.

Incidence of Procedure- or Device- related Major Local Complications at the treated lesion or Puncture Site up to 30 days post-procedure. Major Local Complications include: Iliac arterial rupture, retroperitoneal hematoma, thrombosis of the iliac axis on the ipsilateral side, need for surgery to achieve hemostasis, bleeding with loss of more than 2 g/ dL of hemoglobin, false aneurysm at the puncture site, preventing resumption of walking at 24 hours or appearance of ischemia on the ipsilateral side.
Up to 30 days after index procedure.
Rates of Serious Adverse Events (SAEs)
기간: 1, 6, 12, 24 months after index procedure.

Rates of SAEs, including both related and unrelated events. SAEs will be categorized as related or unrelated to the procedure/device based on adjudication by an Independent Clinical Events Committee.
1, 6, 12, 24 months after index procedure.
Major amputation at target limb rate
기간: 1, 6, 12, 24 months after index procedure.

Percentage of patients with amputations above the ankle of the target leg will be counted.
1, 6, 12, 24 months after index procedure.
Primary sustained clinical improvement
기간: 1, 6, 12, 24 months after index procedure.

Primary sustained clinical improvement defined as a sustained upward shift of 1 category of the Rutherford classification for patients with claudication, and by wound healing and rest pain resolution for patients in critical limb ischemia, without the need for repeated target lesion revascularization in surviving patients.
1, 6, 12, 24 months after index procedure.
Primary patency rates
기간: 6 and 24 months after index procedure.

Primary patency rates, defined as the lack of restenosis without reintervention of the target lesion. Restenosis is defined as a reduction in the luminal diameter of more than 50%, determined by either, duplex ultrasound examination considered as a peak systolic velocity index ≥ 2.4 at the target lesion, or by angio-CT (multiplanar reconstruction). In case of death, the vessel is considered as patent as long as no restenosis was detected during the last visit before the patient died. Outcomes will be computed as the percentage of lesions (Time frame: 6, 24 months after index procedure).
6 and 24 months after index procedure.
Secondary patency rates
기간: 6, 12, 24 months after index procedure.

Secondary patency rates, defined as the patency of the stent following an endovascular or surgical reintervention due to significant in-stent restenosis or occlusion. Outcomes computed as percentage of lesions.
6, 12, 24 months after index procedure.
Target lesion revascularization (TLR) rate
기간: 1, 6, 12, 24 months after index procedure.

Target lesion revascularization (TLR) rate, defined as the need for repeated procedures (endovascular or surgical) due to a problem arising from the lesion initially treated in surviving patients with preserved limbs. Outcomes will be computed as the percentage of lesions.
1, 6, 12, 24 months after index procedure.
Target vessel revascularization (TVR) rate
기간: 1, 6, 12, 24 months after index procedure.

Target vessel revascularization (TVR) rate, defined as the need for repeated procedures (endovascular or surgical) due to a problem arising remote from the vessel initially treated in surviving patients with preserved limbs. Outcomes will be computed as the percentage of lesions.
1, 6, 12, 24 months after index procedure.
Change in Ankle-Brachial Index (ABI) from baseline
기간: 1, 6, 12, 24 months post-procedure.

Change in ABI from baseline.
1, 6, 12, 24 months post-procedure.
Change in Walking Impairment Questionnaire from baseline
기간: 1, 6, 12, 24 months post-procedure.

The Walking Impairment Questionnaire values will be recorded and compared to the baseline values. This questionnaire is a validated tool to assess walking capability in patients with Peripheral Arterial Disease in different situations.
1, 6, 12, 24 months post-procedure.
Change in quality of life from baseline
기간: 1, 6, 12, 24 months post-procedure.

Change in quality of life from baseline, as measured by EQ-5D. The EQ-5D Questionnaire values will be recorded and compared to the baseline values. It is a validated questionnaire to measure the quality of life based on 5 different parameters. Worst possible score in this study would be 0, best possible score would be 1. In addition, the patient indicates her/his current health on an analog scale from 0 (worst) to 100 (best).
1, 6, 12, 24 months post-procedure.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

iVascular S.L.U.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 4월 27일

기본 완료 (실제)

2025년 6월 30일

연구 완료 (실제)

2026년 9월 30일

연구 등록 날짜

최초 제출

2021년 12월 14일

QC 기준을 충족하는 최초 제출

2022년 1월 13일

처음 게시됨 (실제)

2022년 1월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 3일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • iliCo Study

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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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