이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Clinical Trial Evaluating the Safety and Efficacy of Single-use Peripheral Intravascular Shock Wave Catheters Combined With Intravascular Shock Wave Therapy Devices for Peripheral Artery Calcified Lesions.

This trial is a prospective, multicenter, randomized, parallel controlled clinical trial. It to recruit patients with peripheral arterial calcified lesions, who will be randomly assigned in a 1:1 ratio to either the group or the control group. Subjects in the experimental group will use a disposable intra-peripheral vascularwave catheter combined with an intravascular shockwave therapy device to treat peripheral arterial calcified lesions and perform balloon dilation, while subjects in the control group will use a peripheral balloon dilation catheter to treat peripheral arterial calcified lesions and perform balloon dilation.

연구 개요

연구 유형

중재적

등록 (추정된)

158

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

General selection criteria

  1. Age 18 to 80 years old, regardless of gender;
  2. Rutherford grade is 2 to 5
  3. As judged by the investigator, peripheral endovascular treatment is required;
  4. The subject or their legal guardian has been informed of the purpose of the trial, consents to participate and signs the informed consent form;
  5. The subject is willing comply with all assessment requirements in the trial;

Inclusion criteria for angiography:

1) Target lesions are vascular calcified lesions of grade Ⅲ to Ⅳ according to PARC classification: 2 Target lesions are located in native femoral artery and/or popliteal artery; 3) Total of target lesion ≤260mm; if it contains occlusive lesion, length of occlusive segment ≤100mm and total length of target lesion ≤20mm; 4) Target lesions have not undergone any surgical interventions including endovascular therapy and open surgery before, and the stenosis degree target lesion is ≥70% (visual assessment); 5) Reference vessel diameter of target is between 2.5mm and 8.0mm; 6) At least one distal outflow tract of target lesion is (vascular stenosis degree ≤50% by visual assessment), with blood flow reaching foot (not dependent on collateral circulation); or the patient has successfully undergone treatment for target lesion before (i.e., residual stenosis degree ≤30% by visual assessment after treatment, without serious complications); 7) The ipsilateral inflow tract of target lesion is patent (vascular stenosis degree ≤50% by visual assessment), or the patient has successfully undergone treatment for lesion before (i.e., residual stenosis degree ≤30% by visual assessment treatment, without serious complications);

Exclusion Criteria:

General Exclusion Criteria

  1. History of amputation of target limb or planned major amputation (above the ankle
  2. INR > 3 or platelet count < 60×10^9/L;
  3. Patients with known renal insufficiency (ser creatinine >2.5 mg/dL or 220 μmol/L) or renal failure requiring long-term dialysis;
  4. Patients with known contraindications to antiplatelet andagulant therapy;
  5. Patients with known allergies to contrast agents used in endovascular therapy and experimental device materials;
  6. Patients who have receivedbolytic therapy in the target vessel within 14 days prior to signing informed consent; ) Patients who have experienced myocardial infarction within 60 days prior to signing informed consent;

8) Patients who have experienced stroke within 60 days prior to signing informed consent; 9) Women of childbearing age who are pregnant, breastfeeding or planning pregnancy; 10) Patients participating in other medical device or drug clinical trials; 11) Other reasons considered by the investigator as inappropriate for participation in the trial.

Angiography exclusion criteria:

  1. The target vessel has evidence of aneurysm or acute/chronic thrombosis;
  2. The vessel is highly tortuous (the visual arc is greater than 30°);
  3. The guidewire cannot pass through the target lesion; 4 There is in-stent restenosis in the target lesion area;

5) Before treating the lesion with research devices, ablative devices such as cutting balloons, scoring balloons, compliant balloons, mammillary balloons, pronged balloons, plaque excision devices, excimer laser systems, and peripheral throm aspiration catheters need to be used.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: experimental group

The subjects in the experimental group used disposable peripheral intravascular shockwave catheters with intravascular shockwave therapy devices to treat peripheral artery calcification lesions and perform balloon dilatation.

The subjects in the experimental group used disposable peripheral intravascular shockwave catheters combined with intravascular shockwave therapy devices to treat peripheral artery calcification lesions and perform balloon dilatation.

실험적: control group

The subjects in the control group used peripheral balloon dilatation catheters to treat artery calcified lesions and conduct balloon dilatation.

The subjects in the control group used peripheral balloon dilatation catheters to treat peripheral artery calcified lesions and conduct balloon dilatation.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Technical success rate
기간: immediately after surgery

After treatment with the investigational device, residual diameter stenosis of the target lesion is ≤0% and no dissection of grade ≥D is present.

immediately after surgery

2차 결과 측정

결과 측정
측정값 설명
기간
Device success rate
기간: immediately after surgery

The interventional device successfully reached the lesion site, achieved successful expansion without any rupture, was successfully withdrawn.

immediately after surgery
Primary patency rate of target lesions at 30 days after operation
기간: 30 days after operation

No clinically driven target lesion revascularization (CD-TLR) and no target lesionosis detected by imaging examinations

30 days after operation
Changes in ankle-brachial index at 7 days postoperatively or on the day discharge, and at 30 days postoperatively.
기간: 7 days post-operation or the day of discharge, 30 days post-operation
7 days post-operation or the day of discharge, 30 days post-operation
Changes in Rutherford grade at 7 days postoperatively or discharge day, 3 days postoperatively, and 6 months postoperatively
기간: 7 days after surgery or discharge date, 30 days after surgery, 6 months surgery

Changes in Rutherford grade at 7 days postoperatively or discharge day, 3 days postoperatively, and 6 months postoperatively

7 days after surgery or discharge date, 30 days after surgery, 6 months surgery
Incidence rate of clinically driven target lesion revascularization (CD-TLR) at30 days and 6 months after surgery
기간: 30 days after surgery, 6 months after surgery

Incidence rate of clinically driven target lesion revascularization (CD-TLR) at30 days and 6 months after surgery

30 days after surgery, 6 months after surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

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 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 2월 15일

연구 완료 (추정된)

2027년 12월 15일

연구 등록 날짜

최초 제출

2026년 9월 11일

QC 기준을 충족하는 최초 제출

2026년 9월 18일

처음 게시됨 (실제)

2026년 9월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 18일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • LFBYIVL-202512

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

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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