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
Purpose
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.
Condition
- In-Stent Restenosis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 ≤ 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. 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)
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- A non-randomized, single arm cohort of subjects
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental AGENT DCB 40 mm |
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). |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35233
Birmingham, Alabama 35233
More Details
- Status
- Recruiting
- Sponsor
- Boston Scientific Corporation
Detailed Description
Please see NCT04647253 for the prospective, randomized, multi-center, single blind trial comparing AGENT DCB to balloon angioplasty (POBA). The Long Lesion Cohort is a non-randomized, single arm cohort of subjects with ISR of a previously treated lesion ≥ 26 mm and ≤ 36 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.