N/A
Completed N=730
Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)
Source: ClinicalTrials.gov NCT01412164 ↗Enrolled (actual)
730
Serious AEs
16.4%
Results posted
Mar 2016
Primary outcomePrimary: TLF (Target Lesion Failure) Rate — 4.4 percentage of participants with TLF
Summary
The study aims to further assess the safety, efficacy and the performance of its delivery system of FIREHAWK rapamycin-eluting stent up to five years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TLF (Target Lesion Failure) Rate |
4.4 | — |
| SECONDARY Stent Implantation Success Rate (SIS Rate) |
96.8 | — |
| SECONDARY Patient-related Cardiovascular Clinical Composite Endpoints |
112 | — |
| SECONDARY TLF (Target Lesion Failure) |
59 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-75, male or unpregnant women
- Evidence of non-symptomatic ischemia, stable or non-stable angina or past MI
- Native coronary artery target lesion
- Target lesion length =70%
- For each target lesion, Firehawk stent implantation only
- Understand the study purpose, willing to participate and sign the letter of consent
- Acceptance of clinical follow-up
Exclusion Criteria
- Acute MI within 72 hours
- Unprotected LM and intervention-required three-vessel lesions
- Calcified lesion failed in pre-dilation and twisted lesion
- Bridge vessel lesion
- Any stent implanted within one year
- Severe heart failure (HYHA>=III) or LVEF 2.0mg/dl
- Bleeding tendency
- Allergic to aspirin, clopidogrel, ticlopidine, dye, rapamycin and metal
- Life expectation <12 months
- History of not achieving study finish
- No compliances to the protocol
- Heart implantation subjects
Data sourced from ClinicalTrials.gov (NCT01412164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.