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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04647253
Other study ID # S2358
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date May 11, 2021
Est. completion date September 2027

Study information

Verified date May 2024
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 600
Est. completion date September 2027
Est. primary completion date October 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AGENT DCB
Drug coated PTCA balloon catheter
PTCA balloon catheter
PTCA balloon catheter

Locations

Country Name City State
United States Emory University Hospital Atlanta Georgia
United States Heart Hospital of Austin Austin Texas
United States University of Alabama at Birmingham Birmingham Alabama
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States University of Virginia Medical Center Charlottesville Virginia
United States Lindner Center for Research and Education at Christ Hospital Cincinnati Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Baylor Heart and Vascular Hospital Dallas Texas
United States Henry Ford Hospital Detroit Michigan
United States Evanston Hospital Evanston Illinois
United States Inova Fairfax Hospital Falls Church Virginia
United States Houston Methodist Hospital Houston Texas
United States St. Luke's Hospital of Kansas City Kansas City Missouri
United States University of California San Diego La Jolla California
United States St. Anthony Hospital Lakewood Colorado
United States Northside Hospital Lawrenceville Georgia
United States South Denver Cardiology Littleton Colorado
United States Cedars Sinai Medical Center Los Angeles California
United States Wellstar Kennestone Hospital Marietta Georgia
United States Methodist North Hospital Memphis Tennessee
United States Centennial Medical Center Nashville Tennessee
United States Jersey Shore University Medical Center Neptune New Jersey
United States Ochsner Medical Center New Orleans Louisiana
United States Columbia University Medical Center New York New York
United States Montefiore Medical Center New York New York
United States Bergan Cardiology Omaha Nebraska
United States Overland Park Regional Medical Center Overland Park Kansas
United States Rhode Island Hospital Providence Rhode Island
United States Wake Medical Center Raleigh North Carolina
United States St. Francis Hospital Roslyn New York
United States Regions Hospital Saint Paul Minnesota
United States San Francisco Veterans Affairs Medical Center San Francisco California
United States University of Washington Seattle Washington
United States Stanford University Medical Center Stanford California
United States Tallahassee Memorial Hospital Tallahassee Florida
United States Carondelet Medical Group St. Mary's Hospital Tucson Arizona
United States UPMC Pinnacle Health Wormleysburg Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Target Lesion Failure 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
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