Coronary Artery Disease (CAD) Clinical Trial
— DEBORAOfficial title:
Drug-Eluting Balloon Versus Drug-eluting Stent On de Novo coRonary Artery Disease in Patients With High Bleeding Risk
Verified date | October 2021 |
Source | Instituto Nacional de Cardiologia Ignacio Chavez |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized, single-blind, single-center, non-inferiority clinical trial to compare target lesion failure (TLF) at 12 months in high bleeding risk patients undergoing elective coronary percutaneous intervention comparing limus-eluting balloon vs. limus-eluting stents.
Status | Terminated |
Enrollment | 5 |
Est. completion date | September 29, 2021 |
Est. primary completion date | September 29, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients 18 years old or older with an ischemic de-novo lesion(s) in a 2.5 - 4.0 mm reference diameter coronary artery suitable for elective percutaneous coronary intervention, in context of acute coronary syndrome or chronic coronary syndrome with evidence of ischemia by non-invasive study or pressure guidewire that can be treated by DEB or DES, and has at least 1 major or 2 minor Academic Research Consortium High Bleeding Risk criteria: - Major criteria: 1. Anticipated use of long-term oral anticoagulation 2. Severe or end-stage CKD (eGFR <30 mL/min) 3. Hemoglobin < 11 g/dL 4. Spontaneous bleeding requiring hospitalization or transfusion in the last 6 months, or any time, if recurrent. 5. Moderate or severe baseline thrombocytopenia (<100,000/uL) 6. Chronic bleeding diathesis 7. Liver cirrhosis with portal hypertension 8. Active malignancy (excluding nonmelanoma skin cancer) within the past 12 months 9. Previous spontaneous intracranial hemorrhage 10. Previous traumatic intracranial hemorrhage within the past 12 months 11. Presence of Brain arteriovenous malformation (AVM) 12. Moderate or severe ischemic stroke (NIHSS score equal or more than 5) within the past 6 months 13. Non deferrable major surgery while on DAPT 14. Recent major surgery or major trauma within 30 days before PCI - Minor Criteria: 1. Age 75 years old and older 2. Moderate Chronic Kidney Disease (CKD) (eGFR 30-59 mL/min) 3. Hemoglobin 11 - 12.9 g/dL in men and 11 - 11.9 g/dL in women 4. Spontaneous bleeding requiring hospitalization or transfusion within the past 12 months, not meeting major criterion 5. Long term use of NSAIDs or steroids 6. Any ischemic stroke at any time not meeting major criterion Exclusion Criteria: - STEMI undergoing primary PCI - Any ACS undergoing urgent PCI - Cardiogenic shock or resuscitation with uncertain neurological status at arrival to PCI - Unprotected left main lesion - Life expectancy < 12 months - Reference vessel diameter < 2.5 mm or > 4.0 mm - Bifurcation lesion requiring 2-stent technique - Chronic total occlusion - In-stent restenosis - Dissection affecting the flow (TIMI<3) or significant recoil (>30% in main branch, >50% in side branch) after predilatation - Inability to give written consent |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional de Cardiologia "Ignacio Chávez" | Ciudad de México |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Cardiologia Ignacio Chavez |
Mexico,
Alfonso F, Scheller B. State of the art: balloon catheter technologies - drug-coated balloon. EuroIntervention. 2017 Aug 25;13(6):680-695. doi: 10.4244/EIJ-D-17-00494. — View Citation
Collet JP, Thiele H, Barbato E, Barthélémy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Jüni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Sio — View Citation
Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimský P; ESC Scientific Document Gr — View Citation
Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Choi JW, Caputo R, Kanitkar M, McLaurin B, Potluri S, Smith T, Spriggs D, Tolleson T, Nazif T, Parke M, Lee LC, Lung TH, Stone GW; Onyx — View Citation
Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimig — View Citation
Rissanen TT, Uskela S, Eränen J, Mäntylä P, Olli A, Romppanen H, Siljander A, Pietilä M, Minkkinen MJ, Tervo J, Kärkkäinen JM; DEBUT trial investigators. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding r — View Citation
Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Poco — View Citation
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Varenne O, Cook S, Sideris G, Kedev S, Cuisset T, Carrié D, Hovasse T, Garot P, El Mahmoud R, Spaulding C, Helft G, Diaz Fernandez JF, Brugaletta S, Pinar-Bermudez E, Mauri Ferre J, Commeau P, Teiger E, Bogaerts K, Sabate M, Morice MC, Sinnaeve PR; SENIOR — View Citation
Zocca P, Kok MM, van der Heijden LC, Danse PW, Schotborgh CE, Scholte M, Hartmann M, Linssen GCM, Doggen CJM, von Birgelen C. High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Target Lesion Failure (TLF) | Composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target lesion revascularization | 12 months | |
Secondary | Cardiovascular death | Rate of death resulting from cardiovascular causes in each group:
Death caused by acute MI Death caused by sudden cardiac, including unwitnessed, death Death resulting from heart failure Death caused by stroke Death caused by cardiovascular procedures Death resulting from cardiovascular hemorrhage Death resulting from other cardiovascular cause Any MI not clearly attributable to a non-target vessel will be considered as target-vessel MI. Percutaneous coronary intervention (PCI) related MI is termed type 4a MI. |
12 months | |
Secondary | Myocardial Infarction related to the treated vessel | Rate of myocardial infarction related to the treated vessel (according to the 4th international definition of myocardial infarction) in each group: detection of an increase or decrease in cardiac troponin values with at least 1 of the values above the upper reference limit of the 99th percentile and at least 1 of the following conditions :
Symptoms of acute myocardial ischemia. New ischemic changes in the electrocardiogram. Appearance of pathological Q waves. Imaging evidence of loss of viable myocardium or new regional abnormalities in myocardial wall mobility following a pattern compatible with ischemic etiology. Identification of a coronary thrombus by angiography with intracoronary imaging or by autopsy Any MI that cannot be clearly attributed to a vessel other than the revascularized one will be considered as MI related to the treated vessel. |
12 months | |
Secondary | Target Lesion Revascularization | Rate of repeated percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion | 12 months | |
Secondary | Target Vessel Failure (TVF) | Rate of TVF in each group (composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target vessel revascularization) | 12 months | |
Secondary | Target Vessel Revascularization | Rate of repeated percutaneous intervention or surgical bypass of any segment of the target vessel in each group. | 12 months | |
Secondary | Non-cardiovascular death | Rate of any death that is not thought to be the result of a cardiovascular cause in each group:
Death resulting from malignancy Death resulting from pulmonary causes Death caused by infection (includes sepsis) Death resulting from gastrointestinal causes Death resulting from accident/trauma Death caused by other noncardiovascular organ failure Death resulting from other noncardiovascular cause |
12 months | |
Secondary | Major Bleeding | Incidence of bleeding complications according to The Bleeding Academic Research Consortium 2 (BARC-2) scale: 3 or greater | 12 months | |
Secondary | Technical success | Rate of restoration of antegrade Thrombolysis In Myocardial Infarction (TIMI) flow 2 or 3 and a <30% residual stenosis. | Periprocedural | |
Secondary | Subgroup analysis of target lesion failure | Rate of TLF in treatment of bifurcations vs no bifurcation, by vessel size, in diabetes, by clinical Presentation (acute or chronic). | 12 months | |
Secondary | Subgroup analysis of major bleeding events | Rate of BARC 3-5 bleeding events in patients with anticoagulation vs no anticoagulation, by DAPT duration, by inclusion criteria | 12 months |
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