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Trial Outcomes & Findings for NeoVas Bioresorbable Coronary Scaffold First-in-Man Study (NCT NCT02195414)

NCT ID: NCT02195414

Last Updated: 2016-04-11

Results Overview

Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.

Recruitment status

UNKNOWN

Study phase

PHASE1

Target enrollment

31 participants

Primary outcome timeframe

30 days

Results posted on

2016-04-11

Participant Flow

Subjects enrolled into this trial were comprised of male and female subjects from the general interventional cardiology population. The study commenced on June 19, 2014 with the first subject enrolled on this date. The last subject was enrolled September 3, 2014.

Participant milestones

Participant milestones
Measure
NeoVas BCS
Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
Overall Study
STARTED
31
Overall Study
Primary Endpoint
31
Overall Study
COMPLETED
31
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

NeoVas Bioresorbable Coronary Scaffold First-in-Man Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
NeoVas BCS
n=31 Participants
Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
Age, Continuous
59.1 years
STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
Sex: Female, Male
Male
24 Participants
n=5 Participants
Diabetes Mellitus
Yes
7 participants
n=5 Participants
Diabetes Mellitus
No
24 participants
n=5 Participants
Hypertension
Yes
16 participants
n=5 Participants
Hypertension
No
15 participants
n=5 Participants
Angina Categories
Stable angina
7 participants
n=5 Participants
Angina Categories
Unstable angina
23 participants
n=5 Participants
Angina Categories
NSTEMI
1 participants
n=5 Participants
Target vessel location
Left anterior descending artery
17 participants
n=5 Participants
Target vessel location
Left circumflex artery
3 participants
n=5 Participants
Target vessel location
Right coronary artery
11 participants
n=5 Participants
Stent diameter
3.35 millimeter
STANDARD_DEVIATION 0.23 • n=5 Participants
Stent length
19.35 millimeter
STANDARD_DEVIATION 3.54 • n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.

Outcome measures

Outcome measures
Measure
NeoVas BCS
n=31 Participants
Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
Target Lesion Failure(TLF)
Yes
0 participants
Target Lesion Failure(TLF)
No
31 participants

SECONDARY outcome

Timeframe: 6 months

Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.

Outcome measures

Outcome measures
Measure
NeoVas BCS
n=31 Participants
Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
Patient Oriented Composite Endpoint
0 participants

SECONDARY outcome

Timeframe: 6 months

Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: acute

Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In dual lesion setting both lesions must meet clinical procedure success.

Outcome measures

Outcome measures
Measure
NeoVas BCS
n=31 Participants
Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
Acute Success (Clinical Device and Clinical Procedure)
Success
31 participants
Acute Success (Clinical Device and Clinical Procedure)
Failure
0 participants

SECONDARY outcome

Timeframe: 30days

Scaffold thrombosis will be categorized as acute (≤1day), subacute (\>1day ≤30 days) and late (\>30 days). Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion). In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\* in the distribution of the targetlesion within 30 days.

Outcome measures

Outcome measures
Measure
NeoVas BCS
n=31 Participants
Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
Scaffold Thrombosis
0 participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

In-segment In-scaffold, proximal and distal Late lumen loss (mm); In-segment In-scaffold, proximal and distal Minimal lumen diameter(mm); In-segment In-scaffold, proximal and distal Diameter stenosis (%) Angiographic Binary Restenosis (%).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

proportion of covered struts, malapposed struts; neointimal hyperplasia (NIH) area, volume; NIH volume obstruction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome data not reported

Adverse Events

NeoVas BCS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yaling Han, Study Chair of Clinical Trials

The General Hospital of Shenyang Military Region

Phone: +86-024-28856123

Results disclosure agreements

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