Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Boston Scientific Corporation
Conditions:
In-Stent Restenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 les...
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 coho...
Eligibility Criteria
Inclusion
- Clinical
- 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
- 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)
Key Trial Info
Start Date :
October 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06492174
Start Date
October 7 2024
End Date
December 1 2027
Last Update
November 17 2025
Active Locations (11)
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1
Carondelet Medical Group St. Mary's Hospital
Tucson, Arizona, United States, 85745
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
4
Henry Ford Hospital
Detroit, Michigan, United States, 48202