Coronary Artery Disease
Conditions
Brief summary
The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort of its safety, efficacy and delivery system in treating CAD.
Detailed description
The primary endpoint is in-stent late lumen loss after 9 months of the stent implantation. The secondary endpoint is in-stent percent diameter stenosis.This study is based on non-inferior assumption (vs. Xience V), requiring both endpoints reach statistical significance. Prespecified OCT follow-up is planned at 3-Year after index procedure at 3 chosen hospitals.
Interventions
Sponsors
Shanghai MicroPort Medical (Group) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75, male or women who are not pregnant * Evidence of non-symptomatic ischemia, stable or non-stable angina or past heart attack cases * Target lesion is primary, single artery and single lesion of coronary artery * Target lesion vessel length ≤24mm, diameter 2.25mm-4.0mm * Lesion diameter stenosis ≥70% * Candidates understand the study, willing to sign Consent of Agreement and to willing to accept follow-up For long lesion group, at least one target lesion length ≥28mm，diameter 2.5mm-4.0mm, and one lesion needs to implant 33mm 0r 38mm long stent
Exclusion criteria
* Acute heart attack within one week * Chronic complete stenosis (TIMI 0), left main lesion, three branches need to treat, branch vessel diameter ≤2.5mm and bypass lesion * Calcified lesion failed in pre-dilation and twisted lesion * In-stent restenosis * Stent implanted within one year * Severe heart failure (NYHA above III) or left ventricle EF \<40% * Renal function damage, blood creatinine \>2.0mg/dl * Bleeding risk; allergic to drugs and agents used in procedure/treatment * Life expectation \< 12 months * No compliances to the protocol * Heart implantation cases Pre-specified OCT inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 9 Months In-stent Late Lumen Loss | 9 months | To observe in-stent late lumen loss after 9 months of stent implantation It means the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 9 Months In-stent Diameter Stenosis | 9 months | the in-stent diameter stenosis 9 months post-procedure |
| Target Lesion Failure(TLF) Rate | 1 years after index PCI | Percentage of participants with the determination of TLF. TLF is the composite of sudden cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR). |
| TLF(Target Lumen Failure) Rate | 3 years after index PCI (Percutaneous Coronary Intervention) | percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death. |
| TLF(Target Lumen Failure) | 5 years after index PCI | percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death. |
| Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable) | 1 years after index PCI | — |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Xience V DES as Comparative Arm Use Xience V DES as control group
DES implantation: Implant DES for CAD cases | 231 |
| MicroPort Firehawk DES Use MicroPort's new generation of Firehawk drug eluting stent
DES implantation: Implant DES for CAD cases | 227 |
| Total | 458 |
Baseline characteristics
| Characteristic | Xience V DES as Comparative Arm | MicroPort Firehawk DES | Total |
|---|---|---|---|
| Age, Continuous | 59.97 years STANDARD_DEVIATION 9.39 | 58.95 years STANDARD_DEVIATION 9.42 | 59 years STANDARD_DEVIATION 9 |
| Region of Enrollment China | 231 participants | 227 participants | 458 participants |
| Sex: Female, Male Female | 73 Participants | 70 Participants | 143 Participants |
| Sex: Female, Male Male | 158 Participants | 157 Participants | 315 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 225 | 7 / 227 |
| other Total, other adverse events | 0 / 225 | 0 / 227 |
| serious Total, serious adverse events | 46 / 225 | 28 / 227 |
Outcome results
Primary
9 Months In-stent Late Lumen Loss
To observe in-stent late lumen loss after 9 months of stent implantation It means the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure
Time frame: 9 months
Population: Angiographic follow-up at nine months was completed in 87.6% (199/227) of the Firehawk DES group and 87.4% (202/231) of the Xience V DES group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xience V DES as Comparative Arm | 9 Months In-stent Late Lumen Loss | 0.13 mm | Standard Deviation 0.18 |
| MicroPort Firehawk DES | 9 Months In-stent Late Lumen Loss | 0.13 mm | Standard Deviation 0.24 |
Comparison: H0: Pe - Pc≥ ∆, H1: Pe - Pc \< ∆. Pe and Pc are the mean 9-month in-stent late loss for the subject in the Firehawk DES group and the Xience group, respectively. ∆ is the non-inferiority margin. A two-sided upper 95% confidence bound will be calculated for the difference in 9-month in-stent late loss .p-value: 0.9495% CI: [0, 0.29]ANCOVA
Secondary
9 Months In-stent Diameter Stenosis
the in-stent diameter stenosis 9 months post-procedure
Time frame: 9 months
Population: Angiographic follow-up at nine months was completed in 87.6% (199/227) of the Firehawk DES group and 87.4% (202/231) of the Xience V DES group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xience V DES as Comparative Arm | 9 Months In-stent Diameter Stenosis | 11.51 percentage of diameter stenosis | Standard Deviation 7.37 |
| MicroPort Firehawk DES | 9 Months In-stent Diameter Stenosis | 11.85 percentage of diameter stenosis | Standard Deviation 9.67 |
p-value: 0.69Mixed Models Analysis
Secondary
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
Time frame: 5 years after index PCI
Population: 6 patients in Xience V DES group and 10 patients in Firehawk DES group failed to be contacted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Xience V DES as Comparative Arm | Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable) | 1 Participants |
| MicroPort Firehawk DES | Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable) | 0 Participants |
Secondary
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
Time frame: 1 years after index PCI
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Xience V DES as Comparative Arm | Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable) | 0 Participants |
| MicroPort Firehawk DES | Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable) | 0 Participants |
p-value: 1Fisher Exact
Secondary
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
Time frame: 3 years after index PCI
Population: 3 patients in Xience V DES group and 5 patients in Firehawk DES group failed to be contacted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Xience V DES as Comparative Arm | Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable) | 1 Participants |
| MicroPort Firehawk DES | Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable) | 0 Participants |
Secondary
Target Lesion Failure(TLF) Rate
Percentage of participants with the determination of TLF. TLF is the composite of sudden cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Time frame: 1 years after index PCI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Xience V DES as Comparative Arm | Target Lesion Failure(TLF) Rate | 2.2 percentage |
| MicroPort Firehawk DES | Target Lesion Failure(TLF) Rate | 2.2 percentage |
p-value: 1Fisher Exact
Secondary
TLF(Target Lumen Failure)
percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.
Time frame: 5 years after index PCI
Population: 6 patients in Xience V DES group and 10 patients in Firehawk DES group failed to be contacted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Xience V DES as Comparative Arm | TLF(Target Lumen Failure) | 6.67 percentage |
| MicroPort Firehawk DES | TLF(Target Lumen Failure) | 5.99 percentage |
p-value: 0.77Fisher Exact
Secondary
TLF(Target Lumen Failure) Rate
percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.
Time frame: 3 years after index PCI (Percutaneous Coronary Intervention)
Population: 3 patients in Xience V DES group and 5 patients in Firehawk DES group failed to be contacted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Xience V DES as Comparative Arm | TLF(Target Lumen Failure) Rate | 3.51 percentage |
| MicroPort Firehawk DES | TLF(Target Lumen Failure) Rate | 4.05 percentage |
p-value: 0.76Fisher Exact