Clinical trial NCT06492174: 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
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: In-Stent Restenosis
Keywords: Drug coated balloon
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2024-07-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A non-randomized, single arm cohort of subjects
Primary purpose: TREATMENT

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.

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.

Eligibility 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 ≤ 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)

Primary outcomes:
measure: Number of Participants With Target Lesion Failure
timeFrame: 12-month
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Carondelet Medical Group St. Mary's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Cincinnati
country: United States
facility: Lindner Center for Research and Education at Christ Hospital
state: Ohio
city: Wormleysburg
country: United States
facility: UPMC Pinnacle Health
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Robert Yeh, MD
role: PRINCIPAL_INVESTIGATOR
References: