Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Drug-eluting Stent, Sirolimus
Brief summary
The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent SES.
Detailed description
The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent for the treatment for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions \< 20 mm in length in the native coronary arteries with reference vessel diameters between 2.5 mm and 3.5 mm.
Interventions
DEVICEMiStent SES
The MiStent SES is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Sponsors
Micell Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Male/female patients 18-85 years; 2. Stable or unstable angina pectoris, ischemia, or silent ischemia; 3. Planned single, de novo, types A, B1 and B2 coronary lesions; 4. Target lesion located in a native coronary artery; 5. Target lesion vessel diameter 2.5 to 3.5 mm amenable to treatment with a maximum 23 mm long stent; 6. Target lesion \>50% diameter stenosis; 7. Patients eligible for percutaneous coronary intervention (PCI); 8. Acceptable candidate for myocardial revascularization surgery; 9. A patient may have one additional critical non-target lesion. 10. The patient will provide written informed consent.
Exclusion criteria
1. Female of childbearing potential not on some form of birth control with a confirmed negative pregnancy test at baseline; 2. Recent Q-wave myocardial infarction occurred \<72 hours prior to the index procedure. Recent myocardial infarction with elevated levels of cardiac markers; 3. Left ventricular ejection fraction \<30%; 4. Patients in cardiogenic shock; 5. Cerebrovascular accident or transient ischemic attack within 6 months; 6. Active GI bleed within three months; 7. Any prior true anaphylactic reaction to contrast agents; 8. Patient receiving/scheduled to receive chemotherapy within 30-days before or after the index procedure; 9. Patient is receiving immunosuppressive therapy or has known life-limiting immunosuppressive/autoimmune disease; 10. Renal dysfunction (creatinine \> 2.0 mg/dL or 177 µmol/L); 11. Platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; 12. White blood cell count \<3,000 cells/mm3; 13. Hepatic disease; 14. Heart transplant recipient; 15. Known contraindication to dual antiplatelet therapy; 16. Known hypersensitivity to sirolimus, cobalt-chromium, or to medications such as aspirin, heparin, and all three of the following: clopidogrel bisulfate (Plavix), ticlopidine (Ticlid), and Prasugrel (Effient); 17. Life expectancy \<12 months; 18. Any major medical condition that may interfere with the optimal participation of the patient in this study; 19. Patient is currently participating/planning to participate in an investigational drug or another device study prior to completing 12-months follow-up; 20. Target vessel(s) has been treated within 10 mm proximal or distal to target lesion with any type of PCI within a year prior to index procedure; 21. Planned or actual target vessel(s) treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter prior to stent placement; 22. Previous coronary intravascular brachytherapy; 23. Planned coronary angioplasty or coronary artery bypass grafting (CABG)in the first 9 months after the index procedure; 24. Prior PCI of a non-target vessel must be at least 30 days prior to study enrollment; 25. The intent to direct stent the target lesion; 26. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic In-Stent Late Lumen Loss | 8 months | In-stent late lumen loss as measured by the angiographic core laboratory as the difference between the post-procedure minimal lumen diameters (MLD) in the treated segment (stented region) minus the MLD in the same region at follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | 8 hours | Achievement of a final in-stent residual diameter stenosis of \<50% (by QCA), using the assigned device only |
| Lesion Success | 8 hours | Achievement of a final in-stent residual diameter stenosis of \<50% (by QCA) using any percutaneous method |
| Procedural Success | 8 hours | Achievement of a final in-stent residual diameter stenosis of \<50% (by QCA) using the assigned device (including any adjunctive devices) without cardiac death, Myocardial infarction (MI) or repeat revascularization of the target lesion pre-hospital discharge |
| Total Mortality | 240 days | Total mortality (cardiac and non-cardiac) |
| Total Myocardial Infarction (MI) | 240 days | 1. Q-wave MI (QWMI): requires one of the following criteria: the development of new abnormal Q waves in ≥2 contiguous ECG leads not present on the patient's baseline (i.e., before intervention) in association with a \>2x upper limit normal elevation of creatine kinase (CK) levels. In the absence of ECG data, the clinical events committee may adjudicate a Q-wave MI based on the clinical scenario and appropriate cardiac enzyme data; chest pain or other acute symptoms consistent with myocardial ischemia and new pathological Q waves in ≥2 contiguous ECG leads in the absence of timely cardiac enzyme data. 2. Non-Q-wave MI (NQWMI): the elevation of CK levels (≥2 times ULN) with elevated CK-MB enzyme levels in the absence of new pathologic Q waves. |
| Clinically-driven Target Lesion Revascularization (TLR) Rates | 240 days | A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 50% (Angiographic Core Laboratory QCA assessment) and if one of the following occurs: 1. A positive history of recurrent angina pectoris, presumably related to the target vessel; 2. Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; 3. Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); 4. A target lesion revascularization (TLR) with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms. |
| Clinically-driven Target Vessel Revascularization (TVR) Rates | 240 days | A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 50% (Angiographic Core Laboratory QCA assessment) and if one of the following occurs: 1. A positive history of recurrent angina pectoris, presumably related to the target vessel; 2. Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; 3. Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); 4. A target vessel revascularization (TVR) with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms. |
| Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE) | 240 days | Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q-wave and non-Q-wave) and target vessel revascularization (TVR) |
| Target Lesion Failure (TLF) | 240 days | Target lesion failure (TLF) is defined as the composite endpoint of: * cardiac death, * target-lesion myocardial infarction (Q wave or non-Q wave), and * clinically indicated target lesion revascularization |
| Stent Thrombosis | 240 days | The presence of an intracoronary thrombus that originates in the stent or in the segments 5 mm proximal or distal to the stent post-procedure |
| Angiographic Evaluation: In-stent Binary Restenosis | 4 months, 6 months, 8 months | Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography. |
| Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction | 8 months | % neointimal volume obstruction is defined as the neointimal volume divided by stent volume. |
| IVUS Evaluation: % Neointimal Volume Obstruction | 18 months | % neointimal volume obstruction is defined as the neointimal volume divided by stent volume. |
| Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered | 8 months | % stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections. |
| OCT Evaluation: % Stent Strut Uncovered | 18 M | % stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections. |
| Target Vessel Failure (TVF) | 240 days | Target vessel failure (TVF) is defined as the composite endpoint of: * cardiac death, * target-vessel myocardial infarction (Q wave or non-Q wave), and * clinically indicated target vessel revascularization |
Countries
Australia, Belgium, New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MiStent SES The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating). | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | MiStent SES |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 62.6 years STANDARD_DEVIATION 9.95 |
| Gender Female | 8 Participants |
| Gender Male | 22 Participants |
| Region of Enrollment Australia | 1 participants |
| Region of Enrollment Belgium | 12 participants |
| Region of Enrollment New Zealand | 17 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 30 |
| serious Total, serious adverse events | 7 / 30 |
Outcome results
Primary
Angiographic In-Stent Late Lumen Loss
In-stent late lumen loss as measured by the angiographic core laboratory as the difference between the post-procedure minimal lumen diameters (MLD) in the treated segment (stented region) minus the MLD in the same region at follow-up.
Time frame: 8 months
Population: Last observation used, such that patients (n=10) in the 8 month analysis is reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiStent SES | Angiographic In-Stent Late Lumen Loss | 0.09 mm | Standard Deviation 0.1 |
Secondary
Angiographic Evaluation: In-stent Binary Restenosis
Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography.
Time frame: 18 months
Population: Population includes participants from whom data was collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent SES | Angiographic Evaluation: In-stent Binary Restenosis | 0 participants |
Secondary
Angiographic Evaluation: In-stent Binary Restenosis
Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography.
Time frame: 4 months, 6 months, 8 months
Population: Patients evaluated at 4(n=10), 6(n=10) and 8(n=10) months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent SES | Angiographic Evaluation: In-stent Binary Restenosis | 0 participants |
Secondary
Clinically-driven Target Lesion Revascularization (TLR) Rates
A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 50% (Angiographic Core Laboratory QCA assessment) and if one of the following occurs: 1. A positive history of recurrent angina pectoris, presumably related to the target vessel; 2. Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; 3. Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); 4. A target lesion revascularization (TLR) with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms.
Time frame: 240 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent SES | Clinically-driven Target Lesion Revascularization (TLR) Rates | 0 percentage of participants |
Secondary
Clinically-driven Target Vessel Revascularization (TVR) Rates
A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 50% (Angiographic Core Laboratory QCA assessment) and if one of the following occurs: 1. A positive history of recurrent angina pectoris, presumably related to the target vessel; 2. Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; 3. Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); 4. A target vessel revascularization (TVR) with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms.
Time frame: 240 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent SES | Clinically-driven Target Vessel Revascularization (TVR) Rates | 0 percentage of participants |
Secondary
Device Success
Achievement of a final in-stent residual diameter stenosis of \<50% (by QCA), using the assigned device only
Time frame: 8 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent SES | Device Success | 96.67 percentage of participants |
Secondary
Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction
% neointimal volume obstruction is defined as the neointimal volume divided by stent volume.
Time frame: 8 months
Population: Patients evaluated at 4(n=10), 6(n=10) and 8(n=10) months. Only 25/30 patients had evaluable IVUS data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiStent SES | Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction | 8.0 percentage of volume obstruction | Standard Deviation 4.4 |
Secondary
IVUS Evaluation: % Neointimal Volume Obstruction
% neointimal volume obstruction is defined as the neointimal volume divided by stent volume.
Time frame: 18 months
Population: 20 out of 30 participants analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiStent SES | IVUS Evaluation: % Neointimal Volume Obstruction | 11.2 percentage of volume obstruction | Standard Deviation 8.1 |
Secondary
Lesion Success
Achievement of a final in-stent residual diameter stenosis of \<50% (by QCA) using any percutaneous method
Time frame: 8 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent SES | Lesion Success | 100 percentage of participants |
Secondary
OCT Evaluation: % Stent Strut Uncovered
% stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.
Time frame: 18 M
Population: 27 out of 30 patients analyzed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MiStent SES | OCT Evaluation: % Stent Strut Uncovered | 0 percentage of struts uncovered |
Secondary
Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered
% stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.
Time frame: 8 months
Population: Patients evaluated at 4(n=10), 6(n=10) and 8(n=10) months. Only 9/30 patients had evaluable OCT at the 8 month timeframe.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| MiStent SES | Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered | 3.8 percentage of struts uncovered | Full Range 2.87 |
Secondary
Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE)
Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q-wave and non-Q-wave) and target vessel revascularization (TVR)
Time frame: 240 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent SES | Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE) | 3.3 percentage of participants |
Secondary
Procedural Success
Achievement of a final in-stent residual diameter stenosis of \<50% (by QCA) using the assigned device (including any adjunctive devices) without cardiac death, Myocardial infarction (MI) or repeat revascularization of the target lesion pre-hospital discharge
Time frame: 8 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent SES | Procedural Success | 100 percentage of participants |
Secondary
Stent Thrombosis
The presence of an intracoronary thrombus that originates in the stent or in the segments 5 mm proximal or distal to the stent post-procedure
Time frame: 240 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent SES | Stent Thrombosis | 0 percentage of participants |
Secondary
Target Lesion Failure (TLF)
Target lesion failure (TLF) is defined as the composite endpoint of: * cardiac death, * target-lesion myocardial infarction (Q wave or non-Q wave), and * clinically indicated target lesion revascularization
Time frame: 240 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent SES | Target Lesion Failure (TLF) | 0 percentage of participants |
Secondary
Target Vessel Failure (TVF)
Target vessel failure (TVF) is defined as the composite endpoint of: * cardiac death, * target-vessel myocardial infarction (Q wave or non-Q wave), and * clinically indicated target vessel revascularization
Time frame: 240 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent SES | Target Vessel Failure (TVF) | 0 percentage of participants |
Secondary
Total Mortality
Total mortality (cardiac and non-cardiac)
Time frame: 240 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent SES | Total Mortality | 0 percentage of participants |
Secondary
Total Myocardial Infarction (MI)
1. Q-wave MI (QWMI): requires one of the following criteria: the development of new abnormal Q waves in ≥2 contiguous ECG leads not present on the patient's baseline (i.e., before intervention) in association with a \>2x upper limit normal elevation of creatine kinase (CK) levels. In the absence of ECG data, the clinical events committee may adjudicate a Q-wave MI based on the clinical scenario and appropriate cardiac enzyme data; chest pain or other acute symptoms consistent with myocardial ischemia and new pathological Q waves in ≥2 contiguous ECG leads in the absence of timely cardiac enzyme data. 2. Non-Q-wave MI (NQWMI): the elevation of CK levels (≥2 times ULN) with elevated CK-MB enzyme levels in the absence of new pathologic Q waves.
Time frame: 240 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent SES | Total Myocardial Infarction (MI) | 3.3 percentage of participants |