A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)

In-Stent Restenosis Clinical Trial

— AGENT IDE  

Official title:

AGENT IDE: A Prospective, Randomized (2:1), Multicenter Trial to Assess the Safety and Effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04647253
• Other study ID #: S2358
• Status: Active, not recruiting
• Phase: Phase 3
• 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
• 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)

Related Conditions & MeSH terms

• In-Stent Restenosis

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