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

NCT06492174 | Active Not Recruiting Phase 3 FDA Device

• 1 other identifier: 92294616
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of the AGENT IDE study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 36 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.

Conditions

In-Stent Restenosis

Keywords

Drug coated balloon

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

AGENT DCB 40 mm

EXPERIMENTAL

Agent DCB 40 mm 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).

Device: AGENT DCB 40 mm

Interventions

AGENT DCB 40 mm DEVICE

Drug coated PTCA balloon catheter 40 mm size

AGENT DCB 40 mm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 ≤ 36 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (11)

Carondelet Medical Group St. Mary's Hospital

Tucson, Arizona, 85745, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Lindner Center for Research and Education at Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

UPMC Pinnacle Health

Wormleysburg, Pennsylvania, 17053, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

Study Officials

• Robert Yeh, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A non-randomized, single arm cohort of subjects

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: October 7, 2024
• Primary Completion: December 19, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (11)