Coronary Artery Disease
Conditions
Brief summary
A prospective, randomized, active-control, multi-center clinical trial comparing the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to that of the commercially available Resolute IntegrityTM Drug-Eluting Stent. The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, never previously treated coronary artery lesions
Interventions
DEVICECoronary Stenting
Sponsors
Svelte Medical Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria 1. Patient is ≥18 years old; 2. Patient is eligible for percutaneous coronary intervention (PCI); 3. Patient is an acceptable candidate for emergent coronary artery bypass graft (CABG) surgery; 4. Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study; 5. Female subjects of childbearing potential must have a negative pregnancy test within 7-days before the trial procedure; 6. Patient or subject's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Hospital Research Ethics Committee (HREC) of the respective investigational site; and 7. Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed. Angiographic Inclusion Criteria 1. Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries; 2. If a non-target lesion is treated, it must be treated first and only with commercially available PTCA balloons and/or stents. Post PCI of the non-target vessel, all of the following conditions must be met: 1. Residual diameter stenosis \< 30%; 2. Absence of any angiographic complications; 3. Absence of ischemic symptoms; and 4. Absence of significant new arrhythmia or ECG monitoring changes suggestive of ischemia. 3. Reference vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter by visual estimate; 4. Target lesion \< 20 mm in length by visual estimate (the intention is to cover the entire lesion with one stent of adequate length); and 5. Target lesion stenosis ≥ 50% and \< 100% by visual estimate.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic In-Stent Late Lumen Loss (LL) | 6-months post-procedure | Defined as the measurements either within the stented segment or within 5 mm proximal and distal to the stent edges. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Composite of Cardiac Death, MI Attributed to the Target Vessel and Clinically Driven Target Lesion Revascularization | 1 year post-procedure | Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization |
| Number of Participants Composite of All-cause Mortality, Any MI and Any Revascularization, Target Vessel Revascularization or Revascularization of Non Target Vessels | 1 year post-procedure | Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of non target vessels |
| Number of Participants Stent Thrombosis | 1 year post-procedure | The sudden occlusion of a stented coronary artery due to thrombus formation. |
| Number of Participants Acute Success Rates | From index procedure to hospital discharge, an average of 24 hours | Direct Stenting Success, Lesion Success, Procedure Success and Device Failure |
| Number of Participants In-stent and In-segment Angiographic Binary Restenosis Rate | 6-months post-procedure | The rate which restenosis occurs |
| Number of Participants Clinically-driven Target Lesion Revascularization (TLR) | 1 year post-procedure | Clinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as unstable angina, that is, chest pain that increases in frequency, intensity or duration. |
| In-segment Late Lumen Loss | 6-months post-procedure | Late lumen loss is the difference in millimeters between the diameter of a stented segment post-procedure compared with the follow-up angiogram |
| Neointimal Hyperplasia as Measured by OCT | 6-months post procedures | (% lumen volume) |
| Strut Coverage | 6-months post procedure | (% of struts malapposed, protruding non-covered, protruding covered, non-protruding covered) |
| Number of Participants Target Vessel Failure | 1 year post procedure | Composite endpoint of cardiac death, target vessel MI (Q or Non-Q wave), or clinically- driven target vessel revascularization (TVR) by percutaneous or surgical methods. |
| In-stent and In-segment Minimum Lumen Diameter | 6-months post-procedure | Smallest diameter in the stent or segment area |
Countries
Belgium, Czechia, France, Germany, Netherlands, Sweden, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Svelte Drug-Eluting Coronary Stent Coronary Stenting
Coronary Stenting | 108 |
| Medtronic Resolute Integrity Drug-Eluting Stent Coronary Stenting
Coronary Stenting | 51 |
| Total | 159 |
Baseline characteristics
| Characteristic | Svelte Drug-Eluting Coronary Stent | Medtronic Resolute Integrity Drug-Eluting Stent | Total |
|---|---|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 9.9 | 64.2 years STANDARD_DEVIATION 12.4 | 63.2 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment Belgium | 24 participants | 16 participants | 40 participants |
| Region of Enrollment Czechia | 3 participants | 5 participants | 8 participants |
| Region of Enrollment France | 26 participants | 6 participants | 32 participants |
| Region of Enrollment Germany | 7 participants | 1 participants | 8 participants |
| Region of Enrollment Netherlands | 33 participants | 20 participants | 53 participants |
| Region of Enrollment Sweden | 1 participants | 1 participants | 2 participants |
| Region of Enrollment Switzerland | 14 participants | 2 participants | 16 participants |
| Sex: Female, Male Female | 26 Participants | 17 Participants | 43 Participants |
| Sex: Female, Male Male | 82 Participants | 34 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 108 | 0 / 51 |
| other Total, other adverse events | 36 / 108 | 14 / 51 |
| serious Total, serious adverse events | 21 / 108 | 8 / 51 |
Outcome results
Primary
Angiographic In-Stent Late Lumen Loss (LL)
Defined as the measurements either within the stented segment or within 5 mm proximal and distal to the stent edges.
Time frame: 6-months post-procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Svelte Drug-Eluting Coronary Stent | Angiographic In-Stent Late Lumen Loss (LL) | 0.09 mm | Standard Deviation 0.31 |
| Medtronic Resolute Integrity Drug-Eluting Stent | Angiographic In-Stent Late Lumen Loss (LL) | 0.13 mm | Standard Deviation 0.27 |
Secondary
In-segment Late Lumen Loss
Late lumen loss is the difference in millimeters between the diameter of a stented segment post-procedure compared with the follow-up angiogram
Time frame: 6-months post-procedure
Population: 19 Subjects in the Svelte Arm and 11 subjects in the Medtronic Arm did not return for their 6 month follow-up or refused to have the invasive follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Svelte Drug-Eluting Coronary Stent | In-segment Late Lumen Loss | 0.04 mm | Standard Deviation 0.33 |
| Medtronic Resolute Integrity Drug-Eluting Stent | In-segment Late Lumen Loss | -0.02 mm | Standard Deviation 0.3 |
Secondary
In-stent and In-segment Minimum Lumen Diameter
Smallest diameter in the stent or segment area
Time frame: 6-months post-procedure
Population: 19 Subjects in the Svelte Arm and 11 subjects in the Medtronic Arm did not return for their 6 month follow-up or refused to have the invasive follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Svelte Drug-Eluting Coronary Stent | In-stent and In-segment Minimum Lumen Diameter | In-stent minimum lumen diameter | 2.28 mm | Standard Deviation 0.46 |
| Svelte Drug-Eluting Coronary Stent | In-stent and In-segment Minimum Lumen Diameter | In-segment minimum lumen diameter | 2.07 mm | Standard Deviation 0.48 |
| Medtronic Resolute Integrity Drug-Eluting Stent | In-stent and In-segment Minimum Lumen Diameter | In-stent minimum lumen diameter | 2.52 mm | Standard Deviation 0.45 |
| Medtronic Resolute Integrity Drug-Eluting Stent | In-stent and In-segment Minimum Lumen Diameter | In-segment minimum lumen diameter | 2.26 mm | Standard Deviation 0.48 |
Secondary
Neointimal Hyperplasia as Measured by OCT
(% lumen volume)
Time frame: 6-months post procedures
Population: 8 Subjects in the Svelte Arm refused to have the follow-up OCT at 6 months. This was only measureed in the Svelte arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Svelte Drug-Eluting Coronary Stent | Neointimal Hyperplasia as Measured by OCT | 11.3 percentage of lumen volume | Standard Deviation 4.7 |
Secondary
Number of Participants Acute Success Rates
Direct Stenting Success, Lesion Success, Procedure Success and Device Failure
Time frame: From index procedure to hospital discharge, an average of 24 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Svelte Drug-Eluting Coronary Stent | Number of Participants Acute Success Rates | Device Failure | 2 Participants |
| Svelte Drug-Eluting Coronary Stent | Number of Participants Acute Success Rates | Direct Stenting Success | 96 Participants |
| Svelte Drug-Eluting Coronary Stent | Number of Participants Acute Success Rates | Lesion Success | 104 Participants |
| Svelte Drug-Eluting Coronary Stent | Number of Participants Acute Success Rates | Procedure Success | 103 Participants |
| Medtronic Resolute Integrity Drug-Eluting Stent | Number of Participants Acute Success Rates | Procedure Success | 48 Participants |
| Medtronic Resolute Integrity Drug-Eluting Stent | Number of Participants Acute Success Rates | Device Failure | 0 Participants |
| Medtronic Resolute Integrity Drug-Eluting Stent | Number of Participants Acute Success Rates | Lesion Success | 51 Participants |
| Medtronic Resolute Integrity Drug-Eluting Stent | Number of Participants Acute Success Rates | Direct Stenting Success | 45 Participants |
Secondary
Number of Participants Clinically-driven Target Lesion Revascularization (TLR)
Clinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as unstable angina, that is, chest pain that increases in frequency, intensity or duration.
Time frame: 1 year post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Svelte Drug-Eluting Coronary Stent | Number of Participants Clinically-driven Target Lesion Revascularization (TLR) | 2 Participants |
| Medtronic Resolute Integrity Drug-Eluting Stent | Number of Participants Clinically-driven Target Lesion Revascularization (TLR) | 1 Participants |
Secondary
Number of Participants Composite of All-cause Mortality, Any MI and Any Revascularization, Target Vessel Revascularization or Revascularization of Non Target Vessels
Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of non target vessels
Time frame: 1 year post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Svelte Drug-Eluting Coronary Stent | Number of Participants Composite of All-cause Mortality, Any MI and Any Revascularization, Target Vessel Revascularization or Revascularization of Non Target Vessels | 18 Participants |
| Medtronic Resolute Integrity Drug-Eluting Stent | Number of Participants Composite of All-cause Mortality, Any MI and Any Revascularization, Target Vessel Revascularization or Revascularization of Non Target Vessels | 9 Participants |
Secondary
Number of Participants Composite of Cardiac Death, MI Attributed to the Target Vessel and Clinically Driven Target Lesion Revascularization
Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization
Time frame: 1 year post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Svelte Drug-Eluting Coronary Stent | Number of Participants Composite of Cardiac Death, MI Attributed to the Target Vessel and Clinically Driven Target Lesion Revascularization | 4 Participants |
| Medtronic Resolute Integrity Drug-Eluting Stent | Number of Participants Composite of Cardiac Death, MI Attributed to the Target Vessel and Clinically Driven Target Lesion Revascularization | 4 Participants |
Secondary
Number of Participants In-stent and In-segment Angiographic Binary Restenosis Rate
The rate which restenosis occurs
Time frame: 6-months post-procedure
Population: 19 Subjects in the Svelte Arm and 11 subjects in the Medtronic Arm did not return for their 6 month follow-up or refused to have the invasive follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Svelte Drug-Eluting Coronary Stent | Number of Participants In-stent and In-segment Angiographic Binary Restenosis Rate | In-stent angiographic binary restenosis rate | 2 Participants |
| Svelte Drug-Eluting Coronary Stent | Number of Participants In-stent and In-segment Angiographic Binary Restenosis Rate | In-segment angiographic binary restenosis rate | 5 Participants |
| Medtronic Resolute Integrity Drug-Eluting Stent | Number of Participants In-stent and In-segment Angiographic Binary Restenosis Rate | In-stent angiographic binary restenosis rate | 0 Participants |
| Medtronic Resolute Integrity Drug-Eluting Stent | Number of Participants In-stent and In-segment Angiographic Binary Restenosis Rate | In-segment angiographic binary restenosis rate | 0 Participants |
Secondary
Number of Participants Stent Thrombosis
The sudden occlusion of a stented coronary artery due to thrombus formation.
Time frame: 1 year post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Svelte Drug-Eluting Coronary Stent | Number of Participants Stent Thrombosis | 0 Participants |
| Medtronic Resolute Integrity Drug-Eluting Stent | Number of Participants Stent Thrombosis | 0 Participants |
Secondary
Number of Participants Target Vessel Failure
Composite endpoint of cardiac death, target vessel MI (Q or Non-Q wave), or clinically- driven target vessel revascularization (TVR) by percutaneous or surgical methods.
Time frame: 1 year post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Svelte Drug-Eluting Coronary Stent | Number of Participants Target Vessel Failure | 7 Participants |
| Medtronic Resolute Integrity Drug-Eluting Stent | Number of Participants Target Vessel Failure | 5 Participants |
Secondary
Strut Coverage
(% of struts malapposed, protruding non-covered, protruding covered, non-protruding covered)
Time frame: 6-months post procedure
Population: 8 Subjects in the Svelte Arm refused to have the follow-up OCT at 6 months. This was only measured int he Svelte arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Svelte Drug-Eluting Coronary Stent | Strut Coverage | 94.2 % strut coverage | Standard Deviation 9 |