Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled,
double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham
treatment
Treatment Group:
Subjects treated with aBMC using the CardiAMP cell therapy system
Sham Control Group:
Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial
delivery catheter, no administration of aBMC)
Amish Raval, MD
All
21 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03455725
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Inclusion Criteria:
1. Male or female 21 to 80 years of age
2. Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
3. Lack of control of angina symptoms despite maximum tolerated doses of anti-angina
drugs.
4. Evidence of inducible myocardial ischemia on baseline stress testing
5. Obstructive coronary disease unsuitable for conventional revascularization
6. Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week
screening period).
7. Able to complete an exercise tolerance test on the treadmill
8. Left ventricular ejection fraction of greater than or equal to 40% as measured by
echocardiography.
9. Qualification of a pre-procedure screening of bone-marrow aspiration
Exclusion Criteria
Other cardiac or vascular system or other health-related criteria which may be seen in a
patient's history and physical examination.
The ACCEL® Absorbable Hemostat Powder Clinical IDE Trial is designed as a prospective,
multi-center, randomized, non-inferiority, controlled pivotal clinical trial to evaluate the
safety and efficacy of the ACCEL® Absorbable Hemostat Powder as compared to gelatin sponge,
for achieving hemostasis in subjects undergoing cardiovascular, liver, or soft tissue
surgery, when control of oozing to moderate bleeding by standard surgical techniques is
ineffective and/or impractical.
Chris Rokkas
All
22 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04728087
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Inclusion Criteria:
Pre-Surgery:
1. Subject is greater than or equal to 22 years old
2. Subject is undergoing a cardiovascular surgery, liver surgery or soft tissue surgical
procedure
3. Subject is willing and able to provide appropriate (Institutional Review Board (IRB)
approved) informed consent.
4. The subject is willing and able to comply with the requirements of the protocol,
including follow-up evaluations and schedule.
5. The subject is willing to be treated with ACCEL® Absorbable Hemostat Powder
6. The subject is willing to be treated with a commercially available absorbable gelatin
sponge
During Surgery:
7. Subject has not received blood transfusions between screening and application of
investigational product or commercially available absorbable gelatin sponge
8. There is an estimated TBS surface area of ≤ 60 cm2
9. Visual observation of oozing (0.01 g/10s ˂ Flow ˂ 0.04 g/10s), mild (0.04 g/10s ≤ Flow
˂ 0.32 g/10s), or moderate (0.32 g/10s ≤ Flow ˂ 1.01 g/10s) bleeding as validated and
when control by conventional surgical techniques, including but not limited to suture,
ligature and cautery, is ineffective and/or impractical
10. There is an absence of intra-operative complications other than bleeding, which, in
the opinion of the Investigator, may interfere with the assessment of efficacy or
safety
11. There has been no intra-operative use of adjunct hemostat(s) on the target bleeding
site identified for application of the study treatment
Exclusion Criteria:
Pre-Surgery:
1. The subject is pregnant (verified in a manner consistent with institution's standard
of care)
2. Subject is lactating
3. Subject is currently participating in another investigational device or drug trial or
has participated in one in the past 4 weeks (prior to surgery) or is planning to
participate in another research study involving any investigational product within 4
weeks after surgery
4. Subject is a prisoner, a minor or unable to adequately give informed consent due to
mental or physical condition
5. Subject has medical, social, or psychosocial issues that the Investigator believes
could impact the subject's safety or compliance with study procedures
6. Subject has a known allergy to potatoes
7. Subject has a known allergy to porcine collagen/gelatin
8. Subject has a religious or other objection to porcine products
9. Subject is unwilling to receive blood products
10. Subject has history of heparin-induced thrombocytopenia (only for cardiovascular
subjects where heparin use is required)
11. Subject with a baseline abnormality of INR > 2.5 or an aPTT> 100 seconds during
screening that is not explained by current drug treatment (e.g. heparin, warfarin,
etc.).
12. Subjects with platelets < 100 X 109 PLT/L during screening
13. Subject with Aspartate Aminotransferase (AST) or Alanine aminotransferase (ALT) > 3 X
upper limit normal range during screening, except for subjects undergoing liver
resection surgery or with a diagnosis of liver metastases where there is no upper
limit normal for these analytes due to the nature of their disease
14. Subject is unwilling or unable to return for the required follow-up after surgery
During Surgery:
15. Subject has an operative bleeding site which the surgeon is unable or unwilling to
control with a hemostatic agent
16. Extracorporeal cardiopulmonary bypass circuits or blood salvage circuits are to be
used during or after identification of the TBS.
17. There has been intra-operative use of thrombin on the patient.
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