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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug eluting balloon | Experimental | Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug Eluting Balloon | Device | PCI of in-stent restenosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months post-index procedure |
| 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. | 180 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 30 days post-procedure, 12 months, 24 months and 36 months |
| Composite Rate of Target Vessel Failure (TVF) |
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Inclusion Criteria:
Angiographic Inclusion Criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Mutualiste de Grenoble | Grenoble | 38000 | France | |||
| L'Hôpital Privé du Confluent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41759564 | Derived | Alfonso F, Shaburishvili T, Farah B, Gogorishvili I, Monsegu J, Baranauskas A, Bressollette E, Shaburishvili G, Cuesta J, Rivero F, Moreno R, Sabate M. Three-Year Clinical Follow-Up of a Novel Everolimus-Coated Balloon for Patients With In-Stent Restenosis. Am J Cardiol. 2026 May 15;267:39-43. doi: 10.1016/j.amjcard.2026.02.044. Epub 2026 Feb 26. | |
| 39601687 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | 6 months post-index procedure |
|
|
Through 36 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA (28.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clara Yuan , Principal Clinical Scientist | Abbott | +1408-597-7061 | clara.yuan@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2021 | Nov 25, 2024 | Prot_SAP_000.pdf |
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Target vessel failure (TVF) is defined as composite rate of cardiovascular death, target vessel myocardial infarction, and target vessel revascularization (TVR). |
| 30 days post-procedure, 180 days, 12 months, 24 months and 36 months |
| 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. | 12 months, 24 months and 36 months |
| 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. | 180 days, 12 months, 24 months and 36 months |
| 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. | 12 months |
| 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. | 12 months |
| 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. | 12 months |
| Clinical Success (Per Subject) | Clinical success (per subject) defined as technical success without the occurrence of major adverse cardiac events during the procedure. | 12 months |
| Procedural Success | Procedural success (per subject) defined as lesion success without the occurrence of major adverse cardiac events during the procedure. | 12 months |
| Nantes |
| 44000 |
| France |
| Clinique Pasteur | Toulouse | 31300 | France |
| Tbilisi Heart and Vascular Clinic | Tbilisi | 0159 | Georgia |
| Georgian Israeli Research Medical Centre Helsicore | Tbilisi | Georgia |
| Vilniaus universiteto ligoninÄ— Santaros klinikos | Vilnius | 08410 | Lithuania |
| Hospital ClÃnic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Alfonso F, Shaburishvili T, Farah B, Gogorishvili I, Monsegu J, Baranauskas A, Bressollette E, Shaburishvili G, Cuesta J, Rivero F, Moreno R, Sabate M. First-in-man study of a novel everolimus-coated balloon for the treatment of coronary in-stent restenosis. Coron Artery Dis. 2025 Mar 1;36(2):91-98. doi: 10.1097/MCA.0000000000001459. Epub 2024 Nov 27. |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Prior Percutaneous coronary revascularization (Prior PCI) | Count of Participants | Participants |
|
| Participants |
|
|
| 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | millimeters (mm) | 180 days post-procedure |
|
|
|
| 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). | Analysis population includes all intent to treat (ITT) patients with cardiovascular death, target vessel MI and clinically-driven TLR cumulative at each timepoint. | Posted | Count of Participants | Participants | 30 days post-procedure, 12 months, 24 months and 36 months |
|
|
|
| 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 target vessel revascularization (TVR). | Analysis population includes all intent to treat (ITT) patients with cardiovascular death, target vessel MI and TVR cumulative at each timepoint. | Posted | Count of Participants | Participants | 30 days post-procedure, 180 days, 12 months, 24 months and 36 months |
|
|
|
| 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. | Analysis population includes all intent to treat (ITT) patients clinically-driven TLR cumulative at each timepoint. | Posted | Count of Participants | Participants | 12 months, 24 months and 36 months |
|
|
|
| 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. | Analysis population includes all intent to treat (ITT) patients clinically-driven TVR cumulative at each timepoint. | Posted | Count of Participants | Participants | 180 days, 12 months, 24 months and 36 months |
|
|
|
| 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. | Analysis population includes all intent to treat (ITT) patients with access site complications of Hematoma, AV Fistula or Pseudoaneurysm. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Clinical Success (Per Subject) | Clinical success (per subject) defined as technical success without the occurrence of major adverse cardiac events during the procedure. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Procedural Success | Procedural success (per subject) defined as lesion success without the occurrence of major adverse cardiac events during the procedure. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 3 |
| 51 |
| 22 |
| 51 |
| 10 |
| 51 |
| Acute myocardial infarction | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
|
| Myocardial ischemia | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
|
| Adult failure to thrive | General disorders | MedDRA (28.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (28.0) | Systematic Assessment |
|
| Death | General disorders | MedDRA (28.0) | Systematic Assessment |
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| Non cardiac chest pain | General disorders | MedDRA (28.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (28.0) | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA (28.0) | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA (28.0) | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA (28.0) | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (28.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
|
| Vascular graft | Surgical and medical procedures | MedDRA (28.0) | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
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| Peripheral ischaemia | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
|
| Vascular stent restenosis | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (28.0) | Systematic Assessment |
|
| Vascular stent restenosis | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
|
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| 24 months |
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| 36 months |
|
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| 12 months |
|
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| 24 months |
|
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| 36 months |
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| 36 months |
|
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| 24 months |
|
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| 36 months |
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| Title | Measurements |
|---|---|
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