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The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COBRA PzF | Experimental | Cobra PzF plus 14-day DAPT (dual antiplatelet therapy) |
|
| Drug Eluting Stent | Active Comparator | standard FDA-approved DES (Xience/Promus or Resolute) plus 3 or 6-month DAPT (dual anti-platelet therapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COBRA PzF | Device |
| ||
| Drug Eluting Stent |
| Measure | Description | Time Frame |
|---|---|---|
| BARC class >=2 bleeding after hospital discharge (or beyond 14 days, whichever is "later"). | 6 months | |
| Composite of all cause death, myocardial infarction, definite and probable stent thrombosis or ischemic stroke | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of all cause death, myocardial infarction, definite and probable stent thrombosis, ischemia-driven target lesion revascularization or ischemic stroke | 12 months | |
| Composite of cardiac death and myocardial infarction | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adnan Kastrati | ISAResearch Center Deutsches Herzzentrum München | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health Services | Newark | Delaware | 19718 | United States | ||
| University of Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40050141 | Derived | Bresha J, Hug KP, Byrne RA, Lahu S, Cassese S, Colleran R, Ibrahim T, Xhepa E, Bernlochner I, Joner M, Laugwitz KL, Kastrati A, Kufner S, Coughlan JJ; COBRA-REDUCE investigators. Long term follow up of patients treated with a polymer coated non drug-eluting stent in the COBRA-REDUCE trial. Cardiovasc Revasc Med. 2025 Jun;75:15-22. doi: 10.1016/j.carrev.2025.02.014. Epub 2025 Mar 2. | |
| 39405373 |
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|
|
| Ischemia driven target lesion revascularization | 12 months |
| Definite and probable stent thrombosis | 12 months |
| Ischemic stroke | 12 months |
| BARC class 3-5 bleeding | 6 months |
| TIMI major bleeding; TIMI major and minor bleeding | 6 months |
| Acute Success Rates | Device success; Lesion success; Procedure success | procedure |
| Health economic utility | Total cardiovascular and bleeding related costs with cost effectiveness based on events avoided | 12 months |
| Jacksonville |
| Florida |
| 32209 |
| United States |
| Memorial Hospital Jacksonville | Jacksonville | Florida | 32216 | United States |
| Sebastian River Medical Center | Melbourne | Florida | 32901 | United States |
| Mt Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| University of Maryland St. Joseph Medical Center | Towson | Maryland | 21204 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Rutgers Robert Wood Johnson Medical Schoo | New Brunswick | New Jersey | 08901 | United States |
| Northwell Health | Manhasset | New York | 11030 | United States |
| NYU Winthrop Hospital | Mineola | New York | 11501 | United States |
| North Ohio Heart Center | Elyria | Ohio | 44035 | United States |
| Cleveland Clinic | Fairview Park | Ohio | 44126 | United States |
| Mercy St. Vincent Medical Center | Toledo | Ohio | 43608 | United States |
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| Texas Cardiac Center | Lubbock | Texas | 79410 | United States |
| Tyler Cardiovascular Consultants | Tyler | Texas | 75701 | United States |
| Sentara Heart Hospital (Sentara Cardiovascular Research Institute) | Norfolk | Virginia | 23507 | United States |
| Carilion Medical Center | Roanoke | Virginia | 24014 | United States |
| Charleston Area Medical Center | Charleston | West Virginia | 25304 | United States |
| ZNA Middelheim | Antwerp | 2020 | Belgium |
| Aarhus University Hospital | Aarhus | Denmark |
| Clinique Axium | Aix | France |
| Clinique Du Pont De Chaumes | Montauban | France |
| Clinique du Millénaire | Montpellier | 34000 | France |
| Hopital Pitie-Salpitierre | Paris | 75013 | France |
| Höpital George Pompidou | Paris | France |
| Clinique Pasteur | Toulouse | 31300 | France |
| Institut Lorrain du Coeur et Vaisseaux, CHU Nancy-Barbois | Vandœuvre-lès-Nancy | France |
| Universitats Herzzentrum Freibourg | Bad Krozingen | 79819 | Germany |
| Charité - Campus Benjamin Franklin | Berlin | 12203 | Germany |
| Uni-Klinikum Erlangen | Erlangen | Germany |
| St. Josefskrankenhaus | Freiburg im Breisgau | Germany |
| Klinikum Fürth | Fürth | Germany |
| University of Jena | Jena | Germany |
| MediClin Herzzentrum | Lahr | Germany |
| Klinikum Landshut-Achdorf | Landshut | Germany |
| Deutsches Herzzentrum München | Munich | Germany |
| Klinikum Rechts der Isar München | Munich | Germany |
| Universitätsklinikum Regensburg | Regensburg | Germany |
| Hegau Bodensee Klinikum Singen | Singen | Germany |
| Univesitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Ospedale Spaziani | Frosinone | Italy |
| Paula Stradins Clinical University Hospital | Riga | LV-1002 | Latvia |
| Hopital Cantonal Fribourg | Fribourg | Switzerland |
| Kantonspital St Galen | Sankt Gallen | Switzerland |
| Derived |
| Byrne RA, Colleran R, Coughlan JJ, Jauhar R, Maillard L, De Labriolle A, Maeng M, Croft C, Brunner M, Leistner D, Zrenner B, Kollum M, Laugwitz KL, Xhepa E, Mayer K, Lahu S, Joner M, Kirtane A, Mehran R, Barakat M, Urban P, Cutlip DE, Kastrati A; COBRA-REDUCE Investigators. Randomized Trial of COBRA PzF Stenting to Reduce the Duration of Triple Therapy: The COBRA-REDUCE Trial. Circ Cardiovasc Interv. 2024 Oct;17(10):e013735. doi: 10.1161/CIRCINTERVENTIONS.123.013735. Epub 2024 Oct 15. |
| 33608239 | Derived | Colleran R, Joner M, Cutlip D, Urban P, Maeng M, Jauhar R, Barakat M, Michel JM, Mehran R, Kirtane AJ, Maillard L, Kastrati A, Byrne RA; COBRA-REDUCE investigators. Design and Rationale of a Randomized Trial of COBRA PzF Stenting to REDUCE Duration of Triple Therapy (COBRA-REDUCE). Cardiovasc Revasc Med. 2022 Jan;34:17-24. doi: 10.1016/j.carrev.2021.01.022. Epub 2021 Jan 22. |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000789 | Angina, Unstable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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