N/A
N=296
COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01925794 ↗Enrolled (actual)
296
Serious AEs
29.4%
Results posted
Dec 2021
Primary outcome: Primary: Target Vessel Failure (TVF) — 11.38 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- COBRA PzF (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CeloNova BioSciences, Inc.
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Target Vessel Failure (TVF) |
50 | — |
| SECONDARY All Cause Mortality |
34 | — |
| SECONDARY All Cause Mortality |
34 | — |
| SECONDARY All Cause Mortality |
34 | — |
| SECONDARY All Cause Mortality |
34 | — |
| SECONDARY All Cause Mortality |
34 | — |
| SECONDARY Cardiac Mortality |
3.99 | — |
| SECONDARY Cardiac Mortality |
3.99 | — |
| SECONDARY Cardiac Mortality |
3.99 | — |
| SECONDARY Cardiac Mortality |
3.99 | — |
| SECONDARY Cardiac Mortality |
3.99 | — |
| SECONDARY Major Adverse Cardiac Events (MACE) |
22 | — |
| SECONDARY Major Adverse Cardiac Events (MACE) |
22 | — |
| SECONDARY Major Adverse Cardiac Events (MACE) |
22 | — |
| SECONDARY Major Adverse Cardiac Events (MACE) |
22 | — |
| SECONDARY Major Adverse Cardiac Events (MACE) |
22 | — |
| SECONDARY Myocardial Infarction (MI-ARC Definition) |
10.1 | — |
| SECONDARY Myocardial Infarction (MI-ARC Definition) |
10.1 | — |
| SECONDARY Myocardial Infarction (MI-ARC Definition) |
10.1 | — |
| SECONDARY Myocardial Infarction (MI-ARC Definition) |
10.1 | — |
| SECONDARY Myocardial Infarction (MI-ARC Definition) |
10.1 | — |
| SECONDARY Cardiac Death or MI (ARC Definition) |
25 | — |
| SECONDARY Cardiac Death or MI (ARC Definition) |
25 | — |
| SECONDARY Cardiac Death or MI (ARC Definition) |
25 | — |
| SECONDARY Cardiac Death or MI (ARC Definition) |
25 | — |
| SECONDARY Clinically Driven TLR |
13 | — |
| SECONDARY Clinically Driven TLR |
13 | — |
| SECONDARY Clinically Driven TLR |
13 | — |
| SECONDARY Clinically Driven TLR (Clinical and Angiographic Cohorts) |
12 | — |
| SECONDARY Clinically Driven TLR (Clinical Cohorts) |
7.76 | — |
| SECONDARY Clinically Driven TLR (Clinical and Angiographic Cohorts) |
12 | — |
| SECONDARY Clinically Driven TLR (Clinical Cohorts) |
7.76 | — |
| SECONDARY Clinically Driven TVR |
34 | — |
| SECONDARY Clinically Driven TVR |
34 | — |
| SECONDARY Clinically Driven TVR |
34 | — |
| SECONDARY Clinically Driven TVR |
34 | — |
| SECONDARY Target Vessel Failure (TVF) |
50 | — |
| SECONDARY Target Vessel Failure (TVF) |
50 | — |
| SECONDARY Target Vessel Failure (TVF) |
50 | — |
| SECONDARY Stroke (Ischemic and Hemorrhagic) |
2 | — |
| SECONDARY Stroke (Ischemic and Hemorrhagic) |
2 | — |
| SECONDARY Stroke (Ischemic and Hemorrhagic) |
2 | — |
| SECONDARY Device Success |
291 | — |
| SECONDARY Stroke (Ischemic and Hemorrhagic) |
2 | — |
| SECONDARY Lesion Success |
254 | — |
| SECONDARY Procedure Success |
241 | — |
| SECONDARY Bleeding or Vascular Complications |
— | — |
| SECONDARY Early Stent Thrombosis (ARC Definition) |
— | — |
| SECONDARY Late Stent Thrombosis |
— | — |
| SECONDARY Late Stent Thrombosis |
— | — |
| SECONDARY Late Stent Thrombosis |
— | — |
| SECONDARY Definite and Probable Stent Thrombosis |
— | — |
| SECONDARY In-Segment Percent Diameter Stenosis |
38.34; 36.89 | — |
| SECONDARY In-Stent and In-Segment MLD and Late Loss |
0.83; 0.52; 1.78; 1.72 | — |
| SECONDARY Angiographic Endpoints |
28.57; 25.64; 0.00 | — |
| SECONDARY In-stent Neointimal Thickness (INT) |
0.33 | — |
| SECONDARY Percentage of Uncovered and/or Malapposed Struts |
0.00 | — |
| SECONDARY Lumen and Stent Area Measurements |
5.52; 8.41 | — |
| SECONDARY Lumen and Stent Volume |
97.44; 149.06 | — |
Summary
This is a prospective, multi-center, non-randomized, single arm clinical trial that will be conducted at up to 40 sites in the United States and Outside United States (OUS). This study will enroll patients with symptomatic ischemic heart disease due to a single de novo lesion contained within a native coronary artery with reference vessel diameter between 2.5 mm and 4.0 mm and lesion length ≤ 24 mm that is amenable to percutaneous coronary intervention (PCI) and stent deployment. All patients will be followed at 30 days, 6 months, 9 months, 1 year and annually for 5 years post index stenting procedure.
Eligibility Criteria
General Inclusion Criteria:
- Patient >/= to 18 years old.
- Eligible for percutaneous coronary intervention (PCI).
- Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
- Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
- Acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Stable angina pectoris (Canadian Cardiovascular Society (CCS) 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g., ETT, SPECT, Stress echocardiography or Cardiac CT).
- Male or non-pregnant female patient (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).
Angiographic Inclusion Criteria
- Patient indicated for elective stenting of a single stenotic lesion in a native coronary artery.
- Reference vessel >/= 2.5 mm and 50% stenosis.
- Target lesion stenosis >/= 70% and 2.0 mg/dl within 7 days prior to index procedure.
- Patients unable to tolerate dual anti-platelets therapy (DAPT) for one month post procedure.
Angiographic Exclusion Criteria
- Unprotected left main coronary artery disease (obstruction greater than 50% in the left main coronary artery that is not protected by at least one non-obstructed bypass graft to the LAD or Circumflex artery or a branch thereof).
- Target vessel with any lesions with greater than 50% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line QCA.
- Target lesion (or vessel) exhibiting an intraluminal thrombus (occupying > 50% of the true lumen diameter) at any time.
- Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
- Target lesion with side branches > 2.0mm in diameter.
- Target vessel is excessively tortuous (two bends > 90˚ to reach the target lesion).
- Target lesion is severely calcified.
- TIMI flow 0 or 1
- Target lesion is in a bypass graft
Data sourced from ClinicalTrials.gov (NCT01925794). 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.