In-Stent Restenosis
Conditions
Keywords
Drug coated balloon
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.
Interventions
DEVICEAGENT DCB
Drug coated PTCA balloon catheter
DEVICEPTCA balloon catheter
PTCA balloon catheter
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Prospective, Randomized (2:1), Multicenter Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Target Lesion Failure | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert Yeh, MD
Beth Israel Deaconess Medical Center
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
AGENT DCB: Drug coated PTCA balloon catheter | 406 |
| Commercially Available, PTCA Dilation Catheter PTCA balloon catheter: PTCA balloon catheter | 194 |
| Total | 600 |
Baseline characteristics
| Characteristic | Total | Commercially Available, PTCA Dilation Catheter | AGENT DCB |
|---|---|---|---|
| Age, Continuous | 68.25 years STANDARD_DEVIATION 9.75 | 67.90 years STANDARD_DEVIATION 9.68 | 68.42 years STANDARD_DEVIATION 9.79 |
| Body Mass Index | 30.04 kg/m2 STANDARD_DEVIATION 5.64 | 30.10 kg/m2 STANDARD_DEVIATION 5.85 | 30.01 kg/m2 STANDARD_DEVIATION 5.53 |
| Current Diabetes Mellitus | 303 Participants | 97 Participants | 206 Participants |
| History of Myocardial Infarction | 293 Participants | 95 Participants | 198 Participants |
| Race/Ethnicity, Customized American Indian or Alaska native | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 15 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized Black, of African heritage | 42 Participants | 10 Participants | 32 Participants |
| Race/Ethnicity, Customized Caucasian | 452 Participants | 148 Participants | 304 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 35 Participants | 9 Participants | 26 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Disclosed | 41 Participants | 18 Participants | 23 Participants |
| Race/Ethnicity, Customized Other | 19 Participants | 3 Participants | 16 Participants |
| Region of Enrollment United States | 600 participants | 194 participants | 406 participants |
| Sex: Female, Male Female | 157 Participants | 53 Participants | 104 Participants |
| Sex: Female, Male Male | 443 Participants | 141 Participants | 302 Participants |
| Stent Layer in Target Lesion Multiple Layers | 258 Participants | 82 Participants | 176 Participants |
| Stent Layer in Target Lesion Single Layer | 342 Participants | 112 Participants | 230 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 17 / 406 | 8 / 194 |
| other Total, other adverse events | 79 / 406 | 50 / 194 |
| serious Total, serious adverse events | 226 / 406 | 113 / 194 |
Outcome results
Primary
Number of Participants With Target Lesion Failure
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
Time frame: 12-month
Population: The number of participants analyzed excludes subjects with insufficient follow up (i.e. subjects were followed less than 335 days post-procedure) and without experiencing 12-month TLF
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AGENT DCB | Number of Participants With Target Lesion Failure | 71 Participants |
| Commercially Available, PTCA Dilation Catheter | Number of Participants With Target Lesion Failure | 54 Participants |
p-value: 0.002595% CI: [-18.4, -3.3]z-test with unpooled variance