Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Drug-eluting Stent, Sirolimus
Brief summary
The DESSOLVE II 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 in the native coronary arteries.
Detailed description
The DESSOLVE II clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent as compared to the Endeavor DES for the treatment for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions in the native coronary arteries.
Interventions
DEVICEMiStent DES
The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
DEVICEEndeavor DES
The Endeavor is a device/drug combination comprised of two components; a stent and a drug product (everolimus within a durable polymer coating).
Sponsors
Micell Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 and ≤85 years; 2. Stable/unstable angina pectoris (Class I-IV), documented ischemia/silent ischemia; 3. Planned single, de novo, types A, B1 or B2 coronary lesions; 4. Target lesion located in a native coronary artery; 5. Target lesion in vessel ranging from 2.5 to 3.5 mm amenable to treatment (coverage) with a 30 mm long stent; 6. Target lesion with \>50% diameter stenosis; 7. Recent Q-wave (\>72 hours) or non-Q-wave myocardial infarction; 8. Patients eligible for PCI; 9. Candidate for CABG ; 10. A patient may have one additional critical non-target lesion. 11. Patient capable of providing informed consent and is willing to comply with all study requirements.
Exclusion criteria
1. Female patients of childbearing potential who do not have a confirmed negative pregnancy test at baseline and are not on some form of birth control; 2. Recent Q-wave MI \< 72 hours prior to the index procedure. 3. Recent Q- or non-Q-wave MI with still elevated levels of cardiac markers (e.g. CK; and CK-MB if the CK is elevated); 4. LVEF \<30% (within the previous 6-months); 5. Patients in cardiogenic shock; 6. CVA or TIA within the past 6 months; 7. Active GI bleeding within past 3 months; 8. Any prior anaphylactic reaction to contrast agents; 9. Chemotherapy within 30-days before or after the index procedure; 10. Receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease; 11. Renal dysfunction (creatinine \> 2.0 mg/dL or 177 µmol/L); 12. Platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; 13. White blood cell count \<3,000 cells/mm3; 14. Hepatic disease; 15. Heart transplant recipient; 16. Known contraindication to DAPT; 17. Known hypersensitivity to sirolimus, cobalt-chromium, or to medications such as aspirin, heparin and Angiomax (bivalirudin), and all three of the following: clopidogrel bisulfate (Plavix), ticlopidine (Ticlid), and Prasugrel (Effient); 18. Life expectancy less than 12 months; 19. Any major medical condition that may interfere with participation in this study; 20. Patient is currently participating in an investigational drug or another device study and has not completed the follow-up to the primary endpoint, or the patient is planning on participating prior to completing 12-months follow-up; 21. Target vessel has been treated within 10 mm proximal or distal to target lesion with any type of PCI or within a year prior to index procedure; 22. 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; 23. Patient previously treated at any time with brachytherapy; 24. Planned coronary angioplasty or CABG in the first 9 months after the index procedure or any other planned intervention within 30-days post index procedure; 25. Prior PCI of a non-target vessel must be at least 14 days prior to study enrollment; 26. The intent to direct stent the target lesion; 27. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-Stent Late Lumen Loss | 9 months | Measured by the angiographic core laboratory as the difference between the post-procedure MLD in the treated segment (stented region) minus the MLD in the same region at follow-up |
| Major Adverse Cardiac Events (MACE) | 9 months | Defined as death, MI (Qwave and non-Q-wave) and TVR at 9 months post-procedure. Assessed on all patients with adequate follow-up at 270 days. |
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, MI or repeat revascularization of the target lesion pre-hospital discharge. |
| Total Mortality | 9-months | — |
| Total Myocardial Infarct (MI) | 9-months | 1. Q-wave MI (QWMI): requires one of the following criteria: 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 ULN elevation of CK levels; 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 (≥3 times ULN) in the absence of new pathologic Q waves. 3. Peri-Procedural MI post PCI:Q or non-Q-wave MI, as defined above, prior to hospital discharge, or CK-MB elevation \>3xULN within 48 hours post -PCI, with a normal CK-MB at baseline. |
| Clinically-driven Target Lesion Revascularization (TVR) | 9-months | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel (main branch or side branch). The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches, and the target lesion itself. |
| Target Vessel Failure (TVF) | 9-months | Composite endpoint of cardiac death, target-vessel myocardial infarction (Q wave or non-Q wave), and clinically indicated target vessel revascularization |
| Target Lesion Failure (TLF) | 9-months | Composite endpoint of cardiac death, target-lesion myocardial infarction (Q wave or non-Q wave), and clinically indicated target lesion revascularization |
| Stent Thrombosis (Definite/Probable) | 9-months | 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 |
Countries
Belgium, France, Netherlands, New Zealand, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MiStent DES MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating). | 123 |
| Endeavor DES Active Comparator: Endeavor DES | 61 |
| Total | 184 |
Baseline characteristics
| Characteristic | MiStent DES | Endeavor DES | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 62 Participants | 28 Participants | 90 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 33 Participants | 94 Participants |
| Age, Continuous | 64.96 years STANDARD_DEVIATION 10.43 | 65.13 years STANDARD_DEVIATION 10.47 | 65.02 years STANDARD_DEVIATION 10.42 |
| Gender Female | 38 Participants | 16 Participants | 54 Participants |
| Gender Male | 85 Participants | 45 Participants | 130 Participants |
| Region of Enrollment Belgium | 82 participants | 42 participants | 124 participants |
| Region of Enrollment France | 7 participants | 3 participants | 10 participants |
| Region of Enrollment Netherlands | 15 participants | 7 participants | 22 participants |
| Region of Enrollment New Zealand | 4 participants | 3 participants | 7 participants |
| Region of Enrollment Sweden | 5 participants | 1 participants | 6 participants |
| Region of Enrollment United Kingdom | 10 participants | 5 participants | 15 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 47 / 123 | 36 / 61 |
| serious Total, serious adverse events | 53 / 123 | 19 / 61 |
Outcome results
Primary
In-Stent Late Lumen Loss
Measured by the angiographic core laboratory as the difference between the post-procedure MLD in the treated segment (stented region) minus the MLD in the same region at follow-up
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiStent DES | In-Stent Late Lumen Loss | 0.27 mm | Standard Deviation 0.46 |
| Endeavor DES | In-Stent Late Lumen Loss | 0.58 mm | Standard Deviation 0.41 |
Primary
Major Adverse Cardiac Events (MACE)
Defined as death, MI (Qwave and non-Q-wave) and TVR at 9 months post-procedure. Assessed on all patients with adequate follow-up at 270 days.
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent DES | Major Adverse Cardiac Events (MACE) | 4.3 percentage of participants |
| Endeavor DES | Major Adverse Cardiac Events (MACE) | 6.7 percentage of participants |
Secondary
Clinically-driven Target Lesion Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel (main branch or side branch). The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches, and the target lesion itself.
Time frame: 9-months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent DES | Clinically-driven Target Lesion Revascularization (TVR) | 0.9 percentage of patients |
| Endeavor DES | Clinically-driven Target Lesion Revascularization (TVR) | 3.3 percentage of patients |
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 DES | Device Success | 100 percentage of participants |
| Endeavor DES | Device Success | 100 percentage of participants |
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 DES | Lesion Success | 100 percentage of participants |
| Endeavor DES | Lesion Success | 100 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, MI or repeat revascularization of the target lesion pre-hospital discharge.
Time frame: 8 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent DES | Procedural Success | 98.4 percentage of participants |
| Endeavor DES | Procedural Success | 96.7 percentage of participants |
Secondary
Stent Thrombosis (Definite/Probable)
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: 9-months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent DES | Stent Thrombosis (Definite/Probable) | 0 percentage of patients |
| Endeavor DES | Stent Thrombosis (Definite/Probable) | 1.7 percentage of patients |
Secondary
Target Lesion Failure (TLF)
Composite endpoint of cardiac death, target-lesion myocardial infarction (Q wave or non-Q wave), and clinically indicated target lesion revascularization
Time frame: 9-months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MiStent DES | Target Lesion Failure (TLF) | TLF to 30 days | 1.7 percentage of patients |
| MiStent DES | Target Lesion Failure (TLF) | TLF to 180 days | 2.5 percentage of patients |
| MiStent DES | Target Lesion Failure (TLF) | TLF to 270 days | 3.4 percentage of patients |
| Endeavor DES | Target Lesion Failure (TLF) | TLF to 30 days | 3.3 percentage of patients |
| Endeavor DES | Target Lesion Failure (TLF) | TLF to 180 days | 5 percentage of patients |
| Endeavor DES | Target Lesion Failure (TLF) | TLF to 270 days | 5 percentage of patients |
Secondary
Target Vessel Failure (TVF)
Composite endpoint of cardiac death, target-vessel myocardial infarction (Q wave or non-Q wave), and clinically indicated target vessel revascularization
Time frame: 9-months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent DES | Target Vessel Failure (TVF) | 3.4 percentage of patients |
| Endeavor DES | Target Vessel Failure (TVF) | 6.7 percentage of patients |
Secondary
Total Mortality
Time frame: 9-months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent DES | Total Mortality | 0.9 percentage of patients |
| Endeavor DES | Total Mortality | 1.7 percentage of patients |
Secondary
Total Myocardial Infarct (MI)
1. Q-wave MI (QWMI): requires one of the following criteria: 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 ULN elevation of CK levels; 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 (≥3 times ULN) in the absence of new pathologic Q waves. 3. Peri-Procedural MI post PCI:Q or non-Q-wave MI, as defined above, prior to hospital discharge, or CK-MB elevation \>3xULN within 48 hours post -PCI, with a normal CK-MB at baseline.
Time frame: 9-months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiStent DES | Total Myocardial Infarct (MI) | 2.6 percentage of patients |
| Endeavor DES | Total Myocardial Infarct (MI) | 3.3 percentage of patients |