스텐트 내 재협착증(ISR) 환자 치료를 위한 Paclitaxel 코팅 PTCA 풍선 카테터를 평가하기 위한 임상 시험 (AGENT IDE)
2026년 10월 29일 업데이트: Boston Scientific Corporation
에이전트 IDE: 스텐트 내 재협착(ISR) 환자 치료를 위한 AgentTM Paclitaxel 코팅 PTCA 풍선 카테터의 안전성과 유효성을 평가하기 위한 전향적 무작위(2:1) 다기관 시험
AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 26 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.
연구 개요
연구 유형
중재적
등록 (실제)
600
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Alabama
-
Birmingham, Alabama, 미국, 35233
- University of Alabama at Birmingham
-
-
Arizona
-
Tucson, Arizona, 미국, 85745
- Carondelet Medical Group St. Mary's Hospital
-
-
California
-
La Jolla, California, 미국, 92037
- University of California San Diego
-
Los Angeles, California, 미국, 90048
- Cedars Sinai Medical Center
-
San Francisco, California, 미국, 94121
- San Francisco Veterans Affairs Medical Center
-
Stanford, California, 미국, 94305
- Stanford University Medical Center
-
-
Colorado
-
Lakewood, Colorado, 미국, 80216
- St. Anthony Hospital
-
Littleton, Colorado, 미국, 80210
- South Denver Cardiology
-
-
Florida
-
Tallahassee, Florida, 미국, 32308
- Tallahassee Memorial Hospital
-
-
Georgia
-
Atlanta, Georgia, 미국, 30322
- Emory University Hospital
-
Lawrenceville, Georgia, 미국, 30046
- Northside Hospital
-
Marietta, Georgia, 미국, 30060
- Wellstar Kennestone Hospital
-
-
Illinois
-
Evanston, Illinois, 미국, 60201
- Evanston Hospital
-
-
Kansas
-
Overland Park, Kansas, 미국, 66211
- Overland Park Regional Medical Center
-
-
Louisiana
-
New Orleans, Louisiana, 미국, 70121
- Ochsner Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02215
- Beth Israel Deaconess Medical Center
-
Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hospital
-
Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
-
Boston, Massachusetts, 미국, 02111
- Tufts Medical Center
-
-
Michigan
-
Detroit, Michigan, 미국, 48202
- Henry Ford Hospital
-
-
Minnesota
-
Saint Paul, Minnesota, 미국, 55101
- Regions Hospital
-
-
Missouri
-
Kansas City, Missouri, 미국, 64111
- St. Luke's Hospital of Kansas City
-
-
Nebraska
-
Omaha, Nebraska, 미국, 68124
- Bergan Cardiology
-
-
New Jersey
-
Neptune City, New Jersey, 미국, 07753
- Jersey Shore University Medical Center
-
-
New York
-
New York, New York, 미국, 10032
- Columbia University Medical Center
-
New York, New York, 미국, 10467
- Montefiore Medical Center
-
Roslyn, New York, 미국, 11576
- St. Francis Hospital
-
-
North Carolina
-
Raleigh, North Carolina, 미국, 27610
- Wake Medical Center
-
-
Ohio
-
Cincinnati, Ohio, 미국, 45219
- Lindner Center for Research and Education at Christ Hospital
-
Cleveland, Ohio, 미국, 44195
- Cleveland Clinic Foundation
-
-
Pennsylvania
-
Wormleysburg, Pennsylvania, 미국, 17053
- UPMC Pinnacle Health
-
-
Rhode Island
-
Providence, Rhode Island, 미국, 02903
- Rhode Island Hospital
-
-
Tennessee
-
Memphis, Tennessee, 미국, 38104
- Methodist North Hospital
-
Nashville, Tennessee, 미국, 37203
- Centennial Medical Center
-
-
Texas
-
Austin, Texas, 미국, 78756
- Heart Hospital of Austin
-
Dallas, Texas, 미국, 75226
- Baylor Heart and Vascular Hospital
-
Houston, Texas, 미국, 77030
- Houston Methodist Hospital
-
-
Virginia
-
Charlottesville, Virginia, 미국, 22908
- University of Virginia Medical Center
-
Falls Church, Virginia, 미국, 22042
- Inova Fairfax Hospital
-
-
Washington
-
Seattle, Washington, 미국, 98195
- University of Washington
-
-
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
설명
Clinical Inclusion Criteria
- Subject must be at least 18 years of age
- Subject (or legal guardian) understands the trial requirements and the treatment procedures, and provides written informed consent before any trial-specific tests or procedures are performed
- Subject is eligible for percutaneous coronary intervention (PCI)
- Subject is willing to comply with all protocol-required follow-up evaluation
- Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure
Angiographic Inclusion Criteria (visual estimate)
-
In-stent restenosis in a lesion previously treated with either a drug-eluting stent or bare metal stent, located in a native coronary artery with a visually estimated reference vessel diameter (RVD) > 2.0 mm and ≤ 4.0 mm.
-
Target lesion length must be < 26 mm (by visual estimate) and must be covered by only one balloon.
-
Target lesion must have visually estimated stenosis > 50% and < 100% in symptomatic patients (>70% and <100% in asymptomatic patients) prior to lesion pre-dilation.
-
Target lesion must be successfully pre-dilated.
o Note: Successful predilation/pretreatment refers to dilation with a balloon catheter of appropriate length and diameter, or pretreatment with directional or rotational coronary atherectomy, laser or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C. Thrombolysis in Myocardial Infarction (TIMI) grade flow in the target lesion must be >2
-
If a non-target lesion is treated, it must be treated first and must be deemed a success.
- Note: Successful treatment of a non-target lesion is defined as a residual stenosis of ≤ 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of prolonged chest pain or ECG changes consistent with MI.
Clinical Exclusion Criteria
- Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 24 months.
- Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.).
- Subject has planned procedure that may cause non-compliance with the protocol or confound data interpretation.
- Subject is participating in another investigational drug or device clinical study that has not reached its primary endpoint.
- Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure.
- Woman who is pregnant or nursing. (A pregnancy test must be performed within 7 days prior to the index procedure, except for women who definitely do not have child-bearing potential.)
- Left ventricular ejection fraction known to be < 25%.
- Subject had PCI or other coronary interventions within the last 30 days.
- Planned PCI or CABG after the index procedure.
- STEMI or QWMI <72h prior to the index procedure.
- Cardiogenic shock (SBP < 80 mmHg requiring inotropes, IABP or fluid support).
- Known allergies against paclitaxel or other components of the used medical devices.
- Known hypersensitivity or contraindication for contrast dye that in the opinion of the investigator cannot be adequately pre-medicated.
- Intolerance to antiplatelet drugs, anticoagulants required for procedure.
- Platelet count < 100k/mm3 (risk of bleeding) or > 700k/mm3.
- Subject with renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent).
- Subject has suspected or proven COVID-19 at present or within the past 4 weeks with resolution of symptoms.
Angiographic Exclusion Criteria (visual estimate)
- Target lesion is located within a bifurcation with planned treatment of side branch vessel.
- Target lesion is located within a saphenous vein or arterial graft.
- Thrombus present in the target vessel
- > 50% stenosis of an additional lesion proximal or clinically significant distal (>2.0mm RVD) to the target lesion.
- Patient with unprotected left main coronary artery disease. (>50% diameter stenosis)
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 |
|---|---|
|
활성 비교기: 상업적으로 이용 가능한 PTCA 확장 카테터
|
PTCA balloon catheter |
|
실험적: AGENT DCB
Agent DCB is a Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter with a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient, Acetyl-Tri-n-butyl citrate (ATBC). The balloon catheter platform is based on the commercially available BSC Emerge™ PTCA balloon catheter system (K130391). |
Drug coated PTCA balloon catheter |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Target Lesion Failure
기간: 12-month
|
The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death |
12-month
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Robert Yeh, MD, Beth Israel Deaconess Medical Center
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Yeh RW, Bachinsky W, Stoler R, Bateman C, Tremmel JA, Abbott JD, Dohad S, Batchelor W, Underwood P, Allocco DJ, Kirtane AJ. Rationale and design of a randomized study comparing the agent drug coated balloon to plain old balloon angioplasty in patients with In-stent restenosis. Am Heart J. 2021 Nov;241:101-107. doi: 10.1016/j.ahj.2021.07.008. Epub 2021 Jul 24.
- Yeh RW, Shlofmitz R, Moses J, Bachinsky W, Dohad S, Rudick S, Stoler R, Jefferson BK, Nicholson W, Altman J, Bateman C, Krishnaswamy A, Grantham JA, Zidar FJ, Marso SP, Tremmel JA, Grines C, Ahmed MI, Latib A, Tehrani B, Abbott JD, Batchelor W, Underwood P, Allocco DJ, Kirtane AJ; AGENT IDE Investigators. Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial. JAMA. 2024 Mar 26;331(12):1015-1024. doi: 10.1001/jama.2024.1361.
- Kirtane AJ, Shlofmitz R, Moses J, Bachinsky W, Dohad S, Rudick S, Stoler R, Jefferson BK, Nicholson W, Altman J, Bateman C, Krishnaswamy A, Grantham JA, Zidar FJ, Tremmel JA, Grines C, Ahmed MI, Latib A, Tehrani B, Abbott JD, Batchelor W, Cavalcante R, Yeh RW. Paclitaxel-Coated Balloon for the Treatment of Multilayer In-Stent Restenosis: AGENT IDE Subgroup Analysis. J Am Coll Cardiol. 2025 Aug 19;86(7):502-511. doi: 10.1016/j.jacc.2025.05.062.
- Wen J, Dohad S, Shlofmitz R, Moses J, Bachinsky W, Rudick S, Stoler R, Jefferson BK, Nicholson W, Altman J, Neupane S, Croce K, Shunk K, Taylor A, Saybolt MD, Diaz C, Cavalcante R, Yeh RW, Kirtane AJ. Paclitaxel-Coated Balloon for the Treatment of Small Vessel In-Stent Restenosis: A Subgroup Analysis of the AGENT IDE Randomized Trial. JACC Cardiovasc Interv. 2025 Nov 24;18(22):2701-2710. doi: 10.1016/j.jcin.2025.09.032.
- Jamil Y, Kirtane A, Yeh RW, Shlofmitz R, Moses J, Bachinsky W, Dohad S, Rudick S, Stoler R, Jefferson BK, Nicholson W, Altman J, Krishnaswamy A, Alaswad K, Kimmelstiel C, Reitman A, Cavalcante R, Tehrani BN, Batchelor WB. Paclitaxel-Coated Balloon for Treating In-Stent Restenosis in Racial and Ethnic Minority Patients: A Subanalysis From the AGENT IDE Trial. J Am Heart Assoc. 2026 Jan 20;15(2):e043053. doi: 10.1161/JAHA.125.043053. Epub 2026 Jan 19.
- Abbott JD, Kassis N, Latib A, Shlofmitz RA, Moses JW, Bachinsky WB, Dohad S, Rudick SG, Stoler RC, Jefferson BK, Nicholson WJ, Altman JD, Bateman CT, Krishnaswamy A, Cavalcante R, Yeh RW, Kirtane AJ. Predictors of Target Lesion Failure in Patients With In-Stent Restenosis: Insights From the AGENT IDE Trial. Circ Cardiovasc Interv. 2026 Aug 6:e016289. doi: 10.1161/CIRCINTERVENTIONS.125.016289. Online ahead of print.
- Tehrani BN, Vavilin I, Shlofmitz R, Moses J, Bachinsky W, Dohad S, Rudick S, Stoler R, Jefferson BK, Nicholson W, Altman J, Bateman C, Tremmel JA, Abbott JD, Batchelor W, Cavalcante R, Yeh RW, Kirtane AJ. Influence of Chronic Kidney Disease on Outcomes After Paclitaxel-Coated Balloon Angioplasty for Coronary In-Stent Restenosis. Circ Cardiovasc Interv. 2026 Sep 17:e016978. doi: 10.1161/CIRCINTERVENTIONS.126.016978. Online ahead of print.
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)
2021년 5월 11일
기본 완료 (실제)
2023년 10월 2일
연구 완료 (추정된)
2027년 9월 1일
연구 등록 날짜
최초 제출
2020년 11월 23일
QC 기준을 충족하는 최초 제출
2020년 11월 23일
처음 게시됨 (실제)
2020년 11월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 11월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 10월 29일
마지막으로 확인됨
2026년 10월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- S2358
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
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. .