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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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In-Stent Restenosis

Intervention / Treatment
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* Device: AGENT DCB
* Device: PTCA balloon catheter


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, Randomized (2:1), Multicenter Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGENT DCB<br>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<br>* Drug coated PTCA balloon catheter<br>|
| Active Comparator: Commercially available, PTCA Dilation Catheter<br> | Device: PTCA balloon catheter<br>* PTCA balloon catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure Rate | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug coated balloon