In-stent Restenosis
Conditions
Keywords
TP1125, Coronary, CVT, CVT-ISR
Brief summary
The goal of this first in human study is to assess the safety and inhibition of restenosis of the CVT Everolimus-coated PTCA Catheter in the treatment of subjects presenting in-stent restenotic lesions in native coronary arteries.
Detailed description
The CVT-ISR Trial is a prospective, multi-center, open, single arm study enrolling subjects with visually estimated nominal vessel diameter ≥2.0 mm and ≤3.5mm and lesion length ≤24 mm receiving up to two (2) CVT Everolimus CVT EVE-PTCA Catheters. An angiographic follow up, in combination with either Intravascular Ultrasound (IVUS) or Optical Coherence Tomography (OCT), follow-up, will be carried out in a subset of 25 patients at 180 days following the index procedure.
Interventions
DEVICEDrug Eluting Balloon
PCI of in-stent restenosis
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must be at least 18 years of age. 2. Subject or his/her legally authorized representative provides written informed consent prior to any clinical investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site. 3. Subject must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, IVUS/OCT and examinations. Angiographic Inclusion Criteria 1. Target lesion must be located within a stent (bare metal or drug eluting) placed in a native epicardial coronary vessel with visually estimated nominal vessel diameter of ≥2.0mm and ≤3.5mm. 2. Target lesion must measure ≤24 mm in length by visual estimation. 3. The target lesion must be with a visually estimated stenosis of ≥50% and \< 100% with a TIMI flow of ≥1. 4. Non-clinical investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done ≥90 days prior to or planned to be done 6 months after the index procedure. 5. Non-clinical investigation, percutaneous intervention for lesions in the target vessel is allowed if planned to be done 6 months after the index procedure.
Exclusion criteria
1. Subject with known diagnosis of acute myocardial infarction (AMI) within 30 days preceding the index procedure and CK-MB or troponin have not returned within normal limits at the time of procedure. 2. The subject is currently experiencing clinical symptoms consistent with AMI. 3. Subject has current unstable arrhythmia. 4. Subject has a known left ventricular ejection fraction (LVEF) \<25%. 5. Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine and structurally related compounds, everolimus, or contrast sensitivity that cannot be adequately pre-medicated. 6. Subject has known renal insufficiency (e.g., serum creatinine \> 2.5 mg/dL, (i.e. 221 µmol/L) within 7 days prior to index procedure or creatinine clearance \<30mL/min or subject is on dialysis. 7. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. 8. Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months. 9. Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year). 10. Subject is already participating in another clinical investigation that has not yet reached its primary endpoint. 11. Subject is not, in the opinion of the investigator, an acceptable candidate to participate in the study. 12. In-stent lesions for stent are located within an arterial or saphenous vein graft or stent used to treat a previous ISR. 13. The target vessel contains visible thrombus. 14. Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate | 6 months post-index procedure | Composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR). |
| The Primary Effectiveness Endpoint for the CVT-ISR Study: In-stent Late Lumen Loss (LLL) | 180 days post-procedure | In-Stent Late Lumen Loss (LLL) measures the reduction in the luminal diameter of a stented artery over a specified period after stent implantation, typically assessed using angiographic imaging. The unit of measurement for this outcome is expressed in millimeters (mm) or percentage (%), depending on the reporting method. The LLL is calculated by comparing the luminal diameter at a follow-up time point to the post-procedure luminal diameter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically Driven Target Lesion Revascularization (TLR) | 12 months | TLR is defined as any repeat PCI of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. |
| Clinically-driven Target Vessel Revascularization (TVR) | 180 days and 12 months | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion. |
| Rate of Vascular Access Site Complications | 12 months | The rate of vascular access site complications is defined as the combined rate of hematoma, AV fistula or a pseudoaneurysm that required intervention, such as surgical repair, transfusion or a prolonged hospital stay or requiring a new hospital admittance. |
| Composite Rate of Target Lesion Failure (TLF) | 30 days post-procedure and 12 months | TLF is defined as composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR). |
| Technical Success | 12 months | Technical success, defined as achievement of a final in-lesion residual diameter stenosis of \<30% (by QCA), using the CVT Everolimus coated PTCA Catheter without a device malfunction after wire passage through the lesion. |
| Clinical Success (Per Subject) | 12 months | Clinical success (per subject) defined as technical success without the occurrence of major adverse cardiac events during the procedure. |
| Procedural Success | 12 months | Procedural success (per subject) defined as lesion success without the occurrence of major adverse cardiac events during the procedure. |
| Lesion Success: | 12 months | Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of \<30% (by QCA), using any device after wire passage through the lesion. |
| Composite Rate of Target Vessel Failure (TVF) | 30 days post-procedure, 180 days and 12 months | Target vessel failure (TVF) is defined as composite rate of cardiovascular death, target vessel myocardial infarction, and clinically-driven target vessel revascularization (TVR). |
Countries
France, Georgia, Lithuania, Spain
Participant flow
Recruitment details
A total 51 subjects were enrolled in the CVT-ISR study at nine (9) investigational sites in Europe between October 20, 2021, and April 21, 2022.
Participants by arm
| Arm | Count |
|---|---|
| Drug Eluting Balloon Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Drug Eluting Balloon |
|---|---|
| Age, Continuous | 69.2 years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 18 Participants |
| Prior Percutaneous coronary revascularization (Prior PCI) | 51 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 18 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Sex/Gender, Customized Female | 13 Participants |
| Sex/Gender, Customized Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 51 |
| other Total, other adverse events | 21 / 51 |
| serious Total, serious adverse events | 25 / 51 |
Outcome results
Primary
The Primary Effectiveness Endpoint for the CVT-ISR Study: In-stent Late Lumen Loss (LLL)
In-Stent Late Lumen Loss (LLL) measures the reduction in the luminal diameter of a stented artery over a specified period after stent implantation, typically assessed using angiographic imaging. The unit of measurement for this outcome is expressed in millimeters (mm) or percentage (%), depending on the reporting method. The LLL is calculated by comparing the luminal diameter at a follow-up time point to the post-procedure luminal diameter.
Time frame: 180 days post-procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Drug Eluting Balloon | The Primary Effectiveness Endpoint for the CVT-ISR Study: In-stent Late Lumen Loss (LLL) | 0.40 millimeters (mm) | Standard Deviation 0.48 |
Primary
The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate
Composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR).
Time frame: 6 months post-index procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Drug Eluting Balloon | The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate | Target Lesion Failure | 4 Participants |
| Drug Eluting Balloon | The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate | Cardiovascular Death | 1 Participants |
| Drug Eluting Balloon | The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate | Target Vessel MI | 0 Participants |
| Drug Eluting Balloon | The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate | Clinically-Driven Target Lesion Revascularization | 3 Participants |
Secondary
Clinically Driven Target Lesion Revascularization (TLR)
TLR is defined as any repeat PCI of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time frame: 12 months
Population: Analysis population includes all intent to treat (ITT) patients with cardiovascular death, target vessel MI and clinically-driven TLR cumulative at each timepoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug Eluting Balloon | Clinically Driven Target Lesion Revascularization (TLR) | 4 Participants |
Secondary
Clinically-driven Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.
Time frame: 180 days and 12 months
Population: Analysis population includes all intent to treat (ITT) patients with cardiovascular death, target vessel MI and clinically-driven TVR cumulative at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Drug Eluting Balloon | Clinically-driven Target Vessel Revascularization (TVR) | 180 days | 5 Participants |
| Drug Eluting Balloon | Clinically-driven Target Vessel Revascularization (TVR) | 12 months | 7 Participants |
Secondary
Clinical Success (Per Subject)
Clinical success (per subject) defined as technical success without the occurrence of major adverse cardiac events during the procedure.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug Eluting Balloon | Clinical Success (Per Subject) | 48 Participants |
Secondary
Composite Rate of Target Lesion Failure (TLF)
TLF is defined as composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR).
Time frame: 30 days post-procedure and 12 months
Population: Analysis population includes all intent to treat (ITT) patients with cardiovascular death, target vessel MI and clinically-driven TLR cumulative at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Drug Eluting Balloon | Composite Rate of Target Lesion Failure (TLF) | 30 days post-procedure | 1 Participants |
| Drug Eluting Balloon | Composite Rate of Target Lesion Failure (TLF) | 12 months | 5 Participants |
Secondary
Composite Rate of Target Vessel Failure (TVF)
Target vessel failure (TVF) is defined as composite rate of cardiovascular death, target vessel myocardial infarction, and clinically-driven target vessel revascularization (TVR).
Time frame: 30 days post-procedure, 180 days and 12 months
Population: Analysis population includes all intent to treat (ITT) patients with cardiovascular death, target vessel MI and clinically-driven TVR cumulative at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Drug Eluting Balloon | Composite Rate of Target Vessel Failure (TVF) | 30 days post-procedure | 1 Participants |
| Drug Eluting Balloon | Composite Rate of Target Vessel Failure (TVF) | 180 days | 7 Participants |
| Drug Eluting Balloon | Composite Rate of Target Vessel Failure (TVF) | 12 months | 9 Participants |
Secondary
Lesion Success:
Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of \<30% (by QCA), using any device after wire passage through the lesion.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug Eluting Balloon | Lesion Success: | 50 Participants |
Secondary
Procedural Success
Procedural success (per subject) defined as lesion success without the occurrence of major adverse cardiac events during the procedure.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug Eluting Balloon | Procedural Success | 50 Participants |
Secondary
Rate of Vascular Access Site Complications
The rate of vascular access site complications is defined as the combined rate of hematoma, AV fistula or a pseudoaneurysm that required intervention, such as surgical repair, transfusion or a prolonged hospital stay or requiring a new hospital admittance.
Time frame: 12 months
Population: Analysis population includes all intent to treat (ITT) patients with access site complications of Hematoma, AV Fistula or Pseudoaneurysm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Drug Eluting Balloon | Rate of Vascular Access Site Complications | Hematoma | 0 Participants |
| Drug Eluting Balloon | Rate of Vascular Access Site Complications | AV Fistula | 0 Participants |
| Drug Eluting Balloon | Rate of Vascular Access Site Complications | Pseudoaneurysm | 0 Participants |
Secondary
Technical Success
Technical success, defined as achievement of a final in-lesion residual diameter stenosis of \<30% (by QCA), using the CVT Everolimus coated PTCA Catheter without a device malfunction after wire passage through the lesion.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug Eluting Balloon | Technical Success | 47 Participants |