Trial Outcomes & Findings for Clinical Investigation of the MiStent Drug Eluting Stent (DES) in Coronary Artery Disease (NCT NCT01294748)
NCT ID: NCT01294748
Last Updated: 2017-02-08
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
184 participants
Primary outcome timeframe
9 months
Results posted on
2017-02-08
Participant Flow
Participant milestones
| Measure |
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).
|
Endeavor 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).
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
61
|
|
Overall Study
COMPLETED
|
118
|
59
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Investigation of the MiStent Drug Eluting Stent (DES) in Coronary Artery Disease
Baseline characteristics by cohort
| Measure |
MiStent DES
n=123 Participants
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).
|
Endeavor DES
n=61 Participants
Active Comparator: Endeavor DES
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.96 years
STANDARD_DEVIATION 10.43 • n=5 Participants
|
65.13 years
STANDARD_DEVIATION 10.47 • n=7 Participants
|
65.02 years
STANDARD_DEVIATION 10.42 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
62 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Gender
Female
|
38 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Gender
Male
|
85 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
82 participants
n=5 Participants
|
42 participants
n=7 Participants
|
124 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
15 participants
n=5 Participants
|
7 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthsMeasured 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
Outcome measures
| Measure |
MiStent DES
n=103 Participants
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).
|
Endeavor DES
n=52 Participants
Active Comparator: Endeavor DES
|
|---|---|---|
|
In-Stent Late Lumen Loss
|
0.27 mm
Standard Deviation 0.46
|
0.58 mm
Standard Deviation 0.41
|
PRIMARY outcome
Timeframe: 9 monthsDefined 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.
Outcome measures
| Measure |
MiStent DES
n=117 Participants
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).
|
Endeavor DES
n=60 Participants
Active Comparator: Endeavor DES
|
|---|---|---|
|
Major Adverse Cardiac Events (MACE)
|
4.3 percentage of participants
Interval -11.9 to 4.4
|
6.7 percentage of participants
Interval -11.9 to 4.4
|
SECONDARY outcome
Timeframe: 8 hoursAchievement of a final in-stent residual diameter stenosis of \<50% (by QCA), using the assigned device only.
Outcome measures
| Measure |
MiStent DES
n=122 Participants
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).
|
Endeavor DES
n=61 Participants
Active Comparator: Endeavor DES
|
|---|---|---|
|
Device Success
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 8 hoursAchievement of a final in-stent residual diameter stenosis of \<50% (by QCA) using any percutaneous method.
Outcome measures
| Measure |
MiStent DES
n=122 Participants
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).
|
Endeavor DES
n=61 Participants
Active Comparator: Endeavor DES
|
|---|---|---|
|
Lesion Success
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 8 hoursAchievement 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.
Outcome measures
| Measure |
MiStent DES
n=122 Participants
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).
|
Endeavor DES
n=61 Participants
Active Comparator: Endeavor DES
|
|---|---|---|
|
Procedural Success
|
98.4 percentage of participants
|
96.7 percentage of participants
|
SECONDARY outcome
Timeframe: 9-monthsOutcome measures
| Measure |
MiStent DES
n=117 Participants
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).
|
Endeavor DES
n=60 Participants
Active Comparator: Endeavor DES
|
|---|---|---|
|
Total Mortality
|
0.9 percentage of patients
|
1.7 percentage of patients
|
SECONDARY outcome
Timeframe: 9-months1. 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.
Outcome measures
| Measure |
MiStent DES
n=117 Participants
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).
|
Endeavor DES
n=60 Participants
Active Comparator: Endeavor DES
|
|---|---|---|
|
Total Myocardial Infarct (MI)
|
2.6 percentage of patients
|
3.3 percentage of patients
|
SECONDARY outcome
Timeframe: 9-monthsTVR 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.
Outcome measures
| Measure |
MiStent DES
n=117 Participants
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).
|
Endeavor DES
n=60 Participants
Active Comparator: Endeavor DES
|
|---|---|---|
|
Clinically-driven Target Lesion Revascularization (TVR)
|
0.9 percentage of patients
|
3.3 percentage of patients
|
SECONDARY outcome
Timeframe: 9-monthsComposite endpoint of cardiac death, target-vessel myocardial infarction (Q wave or non-Q wave), and clinically indicated target vessel revascularization
Outcome measures
| Measure |
MiStent DES
n=117 Participants
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).
|
Endeavor DES
n=60 Participants
Active Comparator: Endeavor DES
|
|---|---|---|
|
Target Vessel Failure (TVF)
|
3.4 percentage of patients
|
6.7 percentage of patients
|
SECONDARY outcome
Timeframe: 9-monthsComposite endpoint of cardiac death, target-lesion myocardial infarction (Q wave or non-Q wave), and clinically indicated target lesion revascularization
Outcome measures
| Measure |
MiStent DES
n=123 Participants
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).
|
Endeavor DES
n=61 Participants
Active Comparator: Endeavor DES
|
|---|---|---|
|
Target Lesion Failure (TLF)
TLF to 180 days
|
2.5 percentage of patients
|
5 percentage of patients
|
|
Target Lesion Failure (TLF)
TLF to 270 days
|
3.4 percentage of patients
|
5 percentage of patients
|
|
Target Lesion Failure (TLF)
TLF to 30 days
|
1.7 percentage of patients
|
3.3 percentage of patients
|
SECONDARY outcome
Timeframe: 9-monthsThe presence of an intracoronary thrombus that originates in the stent or in the segments 5 mm proximal or distal to the stent post-procedure
Outcome measures
| Measure |
MiStent DES
n=117 Participants
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).
|
Endeavor DES
n=60 Participants
Active Comparator: Endeavor DES
|
|---|---|---|
|
Stent Thrombosis (Definite/Probable)
|
0 percentage of patients
|
1.7 percentage of patients
|
Adverse Events
MiStent DES
Serious events: 53 serious events
Other events: 47 other events
Deaths: 0 deaths
Endeavor DES
Serious events: 19 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MiStent DES
n=123 participants at risk
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).
|
Endeavor DES
n=61 participants at risk
Active Comparator: Endeavor DES
|
|---|---|---|
|
Cardiac disorders
decompensation cordis
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoe
|
0.81%
1/123 • Number of events 1 • 270 days
|
1.6%
1/61 • Number of events 1 • 270 days
|
|
Respiratory, thoracic and mediastinal disorders
lungoedema
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Cardiac disorders
cardiac chest pain
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Cardiac disorders
silent ischemia
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Infections and infestations
pneumonia
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Cardiac disorders
STEMI anterior (caused by acute stent thrombosis)
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
General disorders
acute in-stent thrombosis in mid-lad
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Cardiac disorders
stable angina
|
0.81%
1/123 • Number of events 1 • 270 days
|
3.3%
2/61 • Number of events 2 • 270 days
|
|
Cardiac disorders
angina pectoris
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Infections and infestations
respiratory infection
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Renal and urinary disorders
reversible renal failure due to dehydration
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Gastrointestinal disorders
diarrhea
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
General disorders
sudden death
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Injury, poisoning and procedural complications
accidental fall
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Gastrointestinal disorders
inguinal hernia
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Vascular disorders
in-stent restonosis
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Injury, poisoning and procedural complications
coronary instent restenosis of a non-target lesion
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
General disorders
burning feeling (non-cardiac retrosternal)
|
0.00%
0/123 • 270 days
|
1.6%
1/61 • Number of events 1 • 270 days
|
|
General disorders
bleeding at catherer site
|
0.00%
0/123 • 270 days
|
1.6%
1/61 • Number of events 1 • 270 days
|
|
Nervous system disorders
stenosis left arteria carotis interna
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Cardiac disorders
angina
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Cardiac disorders
cardiac decompensation
|
0.00%
0/123 • 270 days
|
3.3%
2/61 • Number of events 2 • 270 days
|
|
Cardiac disorders
atypical chest pain
|
0.00%
0/123 • 270 days
|
1.6%
1/61 • Number of events 1 • 270 days
|
|
Vascular disorders
occlusions left arteria femoralis
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Injury, poisoning and procedural complications
femoral pseudo-aneursym
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Cardiac disorders
coronary silent ischemia
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
General disorders
thoracic dyscomfort at exercise (non-cardiac)
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
General disorders
atypical thoracic pain
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
General disorders
non-cardiac chest pain
|
1.6%
2/123 • Number of events 2 • 270 days
|
4.9%
3/61 • Number of events 3 • 270 days
|
|
Cardiac disorders
angina complaints
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Skin and subcutaneous tissue disorders
subcutaneous bleeding A. Femoralis
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Gastrointestinal disorders
ischemic colitis
|
0.00%
0/123 • 270 days
|
1.6%
1/61 • Number of events 1 • 270 days
|
|
Gastrointestinal disorders
necrotic small bowel
|
0.00%
0/123 • 270 days
|
1.6%
1/61 • Number of events 1 • 270 days
|
|
Cardiac disorders
sick sinus syndrome
|
1.6%
2/123 • Number of events 2 • 270 days
|
0.00%
0/61 • 270 days
|
|
Cardiac disorders
increasing angina
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Cardiac disorders
severe stenosis of distal rca
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Vascular disorders
aorta stenosis just above
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Vascular disorders
severe claudication
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Vascular disorders
thrombosys of canal of hunter
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Hepatobiliary disorders
cholecystitis
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Gastrointestinal disorders
hemorrargic gastritis
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Cardiac disorders
non Q-wave myocardial infarction
|
0.00%
0/123 • 270 days
|
1.6%
1/61 • Number of events 1 • 270 days
|
|
Vascular disorders
stenosis of arterial iliaca left
|
0.00%
0/123 • 270 days
|
1.6%
1/61 • Number of events 1 • 270 days
|
|
General disorders
epigastric bleed due to ulcers
|
0.00%
0/123 • 270 days
|
1.6%
1/61 • Number of events 1 • 270 days
|
|
Injury, poisoning and procedural complications
restonosis in target vessel, proximal in-stent
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Cardiac disorders
spiral dissection from mid lad to the most distal
|
0.00%
0/123 • 270 days
|
1.6%
1/61 • Number of events 1 • 270 days
|
|
Gastrointestinal disorders
retroperitonial bleeding at femoral bifurcation
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Cardiac disorders
RDA prox. stenose (proximally from the stent)
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Investigations
drop in hemoglobin
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Cardiac disorders
cardiac related chest pain
|
0.00%
0/123 • 270 days
|
1.6%
1/61 • Number of events 1 • 270 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Injury, poisoning and procedural complications
psuedoanerysm
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Vascular disorders
aortic dissection complicated with anastomosis aorta
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Cardiac disorders
stenosis de novo
|
0.00%
0/123 • 270 days
|
1.6%
1/61 • Number of events 1 • 270 days
|
|
Injury, poisoning and procedural complications
restonosis intrastent 1st diagnoal + proxLAD stenos
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Cardiac disorders
atrial ventribular block type III
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Injury, poisoning and procedural complications
instent restenosis in RCA proximal
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Cardiac disorders
myocardial infarction
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
|
Injury, poisoning and procedural complications
postprocedural myocardial infarction
|
0.81%
1/123 • Number of events 1 • 270 days
|
0.00%
0/61 • 270 days
|
Other adverse events
| Measure |
MiStent DES
n=123 participants at risk
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).
|
Endeavor DES
n=61 participants at risk
Active Comparator: Endeavor DES
|
|---|---|---|
|
Cardiac disorders
angina pectoris
|
10.6%
13/123 • Number of events 13 • 270 days
|
14.8%
9/61 • Number of events 9 • 270 days
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/123 • 270 days
|
6.6%
4/61 • Number of events 4 • 270 days
|
|
General disorders
catherer site hematoma
|
5.7%
7/123 • Number of events 7 • 270 days
|
8.2%
5/61 • Number of events 5 • 270 days
|
|
General disorders
chest pain
|
0.00%
0/123 • 270 days
|
4.9%
3/61 • Number of events 3 • 270 days
|
|
General disorders
non-cardiac chest pain
|
10.6%
13/123 • Number of events 13 • 270 days
|
13.1%
8/61 • Number of events 8 • 270 days
|
|
Nervous system disorders
headache
|
5.7%
7/123 • Number of events 7 • 270 days
|
6.6%
4/61 • Number of events 4 • 270 days
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.00%
0/123 • 270 days
|
4.9%
3/61 • Number of events 3 • 270 days
|
|
Vascular disorders
hypertension
|
5.7%
7/123 • Number of events 7 • 270 days
|
0.00%
0/61 • 270 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60