Trial Outcomes & Findings for First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease (NCT NCT01247428)

NCT ID: NCT01247428

Last Updated: 2016-12-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: 8 months
• Results posted on: 2016-12-19

Participant Flow

Participant milestones

Measure	MiStent 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).
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease

Baseline characteristics by cohort

Measure	MiStent SES n=30 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	62.6 years STANDARD_DEVIATION 9.95 • n=5 Participants
Gender Female	8 Participants n=5 Participants
Gender Male	22 Participants n=5 Participants
Region of Enrollment Belgium	12 participants n=5 Participants
Region of Enrollment Australia	1 participants n=5 Participants
Region of Enrollment New Zealand	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 months

Population: Last observation used, such that patients (n=10) in the 8 month analysis is reported.

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.

Outcome measures

Measure	MiStent SES n=10 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Angiographic In-Stent Late Lumen Loss	0.09 mm Standard Deviation 0.10

SECONDARY outcome

Timeframe: 240 days

Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q-wave and non-Q-wave) and target vessel revascularization (TVR)

Outcome measures

Measure	MiStent SES n=30 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE)	3.3 percentage of participants Interval 0.1 to 17.2

SECONDARY outcome

Timeframe: 8 hours

Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only

Outcome measures

Measure	MiStent SES n=30 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Device Success	96.67 percentage of participants Interval 82.78 to 99.92

SECONDARY outcome

Timeframe: 8 hours

Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method

Outcome measures

Measure	MiStent SES n=30 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Lesion Success	100 percentage of participants Interval 88.43 to 100.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	MiStent SES n=30 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Procedural Success	100 percentage of participants Interval 88.43 to 100.0

SECONDARY outcome

Timeframe: 240 days

Total mortality (cardiac and non-cardiac)

Outcome measures

Measure	MiStent SES n=30 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Total Mortality	0 percentage of participants Interval 0.0 to 11.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MiStent SES n=30 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Total Myocardial Infarction (MI)	3.3 percentage of participants Interval 0.1 to 17.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MiStent SES n=30 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Clinically-driven Target Lesion Revascularization (TLR) Rates	0 percentage of participants Interval 0.0 to 11.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MiStent SES n=30 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Clinically-driven Target Vessel Revascularization (TVR) Rates	0 percentage of participants Interval 0.0 to 11.6

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	MiStent SES n=30 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Target Vessel Failure (TVF)	0 percentage of participants Interval 0.0 to 11.6

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	MiStent SES n=30 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Target Lesion Failure (TLF)	0 percentage of participants Interval 0.0 to 11.6

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	MiStent SES n=30 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Stent Thrombosis	0 percentage of participants Interval 0.0 to 11.6

SECONDARY outcome

Timeframe: 4 months, 6 months, 8 months

Population: Patients evaluated at 4(n=10), 6(n=10) and 8(n=10) months.

Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography.

Outcome measures

Measure	MiStent SES n=30 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Angiographic Evaluation: In-stent Binary Restenosis	0 participants Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: 18 months

Population: Population includes participants from whom data was collected.

Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography.

Outcome measures

Measure	MiStent SES n=27 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Angiographic Evaluation: In-stent Binary Restenosis	0 participants Interval 0.0 to

SECONDARY outcome

Timeframe: 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.

% neointimal volume obstruction is defined as the neointimal volume divided by stent volume.

Outcome measures

Measure	MiStent SES n=25 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction	8.0 percentage of volume obstruction Standard Deviation 4.4

SECONDARY outcome

Timeframe: 18 months

Population: 20 out of 30 participants analyzed

% neointimal volume obstruction is defined as the neointimal volume divided by stent volume.

Outcome measures

Measure	MiStent SES n=20 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
IVUS Evaluation: % Neointimal Volume Obstruction	11.2 percentage of volume obstruction Standard Deviation 8.1

SECONDARY outcome

Timeframe: 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.

% stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.

Outcome measures

Measure	MiStent SES n=9 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered	3.8 percentage of struts uncovered Full Range 2.87 • Interval 0.0 to 8.5

SECONDARY outcome

Timeframe: 18 M

Population: 27 out of 30 patients analyzed

% stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.

Outcome measures

Measure	MiStent SES n=27 Participants The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
OCT Evaluation: % Stent Strut Uncovered	0 percentage of struts uncovered Interval 0.0 to 3.4

Adverse Events

MiStent SES

Serious events: 7 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	MiStent SES n=30 participants at risk The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Cardiac disorders Angina pectoris	6.7% 2/30 Regular investigator assessment.
Cardiac disorders Arteriospasm coronary	3.3% 1/30 Regular investigator assessment.
Cardiac disorders Atrial fibrillation	3.3% 1/30 Regular investigator assessment.
Cardiac disorders Atrioventricular block	3.3% 1/30 Regular investigator assessment.
Nervous system disorders Cerebrovascular accident	3.3% 1/30 Regular investigator assessment.
Nervous system disorders Hemiparesis	3.3% 1/30 Regular investigator assessment.
Nervous system disorders Lacunar infarction	3.3% 1/30 Regular investigator assessment.
Nervous system disorders Sensory disturbance	3.3% 1/30 Regular investigator assessment.

Other adverse events

Measure	MiStent SES n=30 participants at risk The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Cardiac disorders Angina pectoris	10.0% 3/30 Regular investigator assessment.
Musculoskeletal and connective tissue disorders Back pain	10.0% 3/30 Regular investigator assessment.
Nervous system disorders Dizziness	10.0% 3/30 Regular investigator assessment.
Skin and subcutaneous tissue disorders Increase tendency to bruise	6.7% 2/30 Regular investigator assessment.
Surgical and medical procedures Hypertension	10.0% 3/30 Regular investigator assessment.

Additional Information

Dennis Donohoe, MD, Chief Medical Advisor

Micell Technologies

Phone: 919-313-2102

Email: ddonohoeconsult@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60