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

Phase 3

Active, not recruiting

• Conditions: In-Stent Restenosis
• Interventions: Device: PTCA balloon catheter; Device: AGENT DCB

• Registration Number: NCT04647253
• Lead Sponsor: Boston Scientific Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-11-23
• Study First Posted: 2020-11-30
• Study Start: 2021-05-11
• Primary Completion: 2023-10-02
• Results First Submitted: 2024-04-11
• Results First Submitted QC: 2024-05-30
• Results First Posted: 2024-05-31
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-25
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Commercially available, PTCA Dilation Catheter	PTCA balloon catheter	-
AGENT DCB	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).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Target Lesion Failure	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

Trial Locations

Locations (40)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Carondelet Medical Group St. Mary's Hospital; 🇺🇸 Tucson, Arizona, United States

University of California San Diego; 🇺🇸 La Jolla, California, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

San Francisco Veterans Affairs Medical Center; 🇺🇸 San Francisco, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

St. Anthony Hospital; 🇺🇸 Lakewood, Colorado, United States

South Denver Cardiology; 🇺🇸 Littleton, Colorado, United States

Tallahassee Memorial Hospital; 🇺🇸 Tallahassee, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

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