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Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)
This study is ongoing, but not recruiting participants.
Sponsor:
Shanghai MicroPort Medical (Group) Co., Ltd.
Information provided by (Responsible Party):
Shanghai MicroPort Medical (Group) Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01412164
First received: August 5, 2011
Last updated: February 19, 2016
Last verified: February 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
| Coronary Artery Disease | Device: FIREHAWK biodegradable polymer rapamycin-eluting stent |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Multicenter Single-Arm Observational Registry Study Assessing the Safety and Efficacy of FIREHAWK Biodegradable Polymer Target-release Rapamycin-eluting Stent for the Treatment of Coronary Artery Disease: TARGET II |
Resource links provided by NLM:
Further study details as provided by Shanghai MicroPort Medical (Group) Co., Ltd.:
Primary Outcome Measures:
- Device Related Cardiovascular Composite Endpoint [ Time Frame: 12 months ]Device-related cardiovascular composite endpoint, including cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure
Secondary Outcome Measures:
- Stent Implantation Success Rate [ Time Frame: 5 years ]30 days, 6 months, and 2-5 years TLF, cardiovascular composite endpoints, ARC defined stent thrombosis
| Enrollment: | 730 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | February 2017 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Firehawk
Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD
|
Device: FIREHAWK biodegradable polymer rapamycin-eluting stent
DES PCI for CAD
|
Detailed Description:
This is a prospective open-labeled, multi-center, single-arm observational registry study. Approximately 1,100 subjects will be enrolled to evaluate the TLF as the primary endpoint at 12-month. Also, the study will follow up those subjects up to 5 years as the secondary endpoints.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 <=60mm, target lesion vessel diameter 2.25mm-4.0mm
- Target lesion diamter stenosis>=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:
- Actue 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<40%
- Renal deficiency, blood creatinine > 2.0mg/dl
- Bleeding tendency
- Allergic to aspirin, clopidogrel, ticlopidine, dye, ramapycin and metal
- Life expectation <12 months
- History of not achieving study finish
- No compliances to the protocol
- Heart implantation subjects
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412164
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412164
Locations
| China | |
| Fuwai Hospital | |
| Beijing, China | |
Sponsors and Collaborators
Shanghai MicroPort Medical (Group) Co., Ltd.
Investigators
| Principal Investigator: | Runlin Gao, M.D., Prof. | Fu Wai Hospital, Beijing, China |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Shanghai MicroPort Medical (Group) Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01412164 History of Changes |
| Other Study ID Numbers: |
TARGET II |
| Study First Received: | August 5, 2011 |
| Results First Received: | February 19, 2016 |
| Last Updated: | February 19, 2016 |
Keywords provided by Shanghai MicroPort Medical (Group) Co., Ltd.:
|
DES CAD FIREHAWK MicroPort PCI |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Sirolimus |
Everolimus Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antineoplastic Agents Antifungal Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017