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Trial record 1 of 1 for:    NCT04647253
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A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) (AGENT IDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04647253
Recruitment Status : Active, not recruiting
First Posted : November 30, 2020
Last Update Posted : May 23, 2023
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
In-Stent Restenosis Device: AGENT DCB Device: PTCA balloon catheter Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Randomized (2:1), Multicenter Trial
Masking: Single (Participant)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 11, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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).
 Device: AGENT DCB
Drug coated PTCA balloon catheter
Active Comparator: Commercially available, PTCA Dilation Catheter Device: PTCA balloon catheter
PTCA balloon catheter


Outcome Measures
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Primary Outcome Measures :
  1. Target Lesion Failure Rate [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04647253


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Robert Yeh, MD Beth Israel Deaconess Medical Center
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04647253    
Other Study ID Numbers: S2358
First Posted: November 30, 2020    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Boston Scientific Corporation:
Drug coated balloon