Clinical Program
| STUDY NAME | TYPE OF STUDY | TOTAL PATIENTS | STATUS | LINKS |
|---|---|---|---|---|
| Cardiac Surgery | ||||
| Dafodil™ Pericardial Bioprosthesis | ||||
| Dafodil PMCF | Retrospective study | 338 | Recruitment ongoing | - |
| DICTATE | Prospective, investigator initiated study | 13 out of 150 | Recruitment ongoing | - |
| DAWN India | Ambispective, Post-market, Multi-center, Single-arm, Real-world Observational Registry | 20 out of 300 | Recruitment ongoing | - |
| Dafodil Neo Study | Single centre, Single-arm, Ambispective, Observational study | 150 | Recruitment ongoing | - |
| NEOCARE | Prospective, Single Center, Single Arm | 70 | Recruitment ongoing | - |
| Dafodil Euro Registry | Prospective , multi-centre, single-arm | 550 | Recruitment ongoing | - |
| Dafodil Euro Registry | Retrospective, multi-centre, single-arm | 500 | Recruitment ongoing | - |
| Dafodil Kazakhstan Registry | prospective,single arm Multicenter registry | 500 | Recruitment ongoing | - |
| Dafodil Brazil | prospective,single arm Multicenter registry | 300 | Recruitment ongoing | - |
| Dafodil-1 Trial | Prospective, multi-center, single-arm | 136 | Follow-up ongoing | - |
| MILTONIA™ Mechanical Bi-Leaflet Heart Valve | ||||
| Sponsor Initiated Study | ||||
| MILTONIA Study | Ambispective, multi-centre, single-arm | 200 | Recruitment ongoing | - |
| Flomero™ pericardial bioprosthesis | ||||
| FLORENCE | prospective, single-arm, single-center study | 100 | Recruitment ongoing | - |
| CARDIOVASCULAR AND STRUCTURAL HEART | ||||
| BioMime™ Sirolimus Eluting Coronary Stent System | ||||
| meriT-1 study | Prospective, non-randomised, single-arm, single-center study | 30 | Completed | Know More |
| meriT-2 study | Prospective, non-randomised, single-arm, multi-center study | 250 | Completed | Know More |
| meriT-3 study | Retrospective, multi-center study | 1161 | Completed | Know More |
| meriT-V study | Prospective, multi-center, RCT | 256 | Completed | Know More |
| MILES-UK Registry | Post-marketing surveillance, single-arm study | 759 | Completed | Know More |
| MILES-GLOBAL study | Prospective registry | 760 | Completed | Know More |
| BioMime single-center real world study | Retrospective, observational, single-center study | 1188 | Completed | - |
| The Billar registry | Prospective, multi-center, non-randomized study | 696 | Completed | - |
| BioMime single-center retrospective analysis | Retrospective, single-center, non-randomized study | 73 | Completed | - |
| SLS vs OMS in very long coronary lesions | Historical cohort study | 124 out of 1709 | Completed | - |
| BioMime GBPR Study | Retrospective, single-center study | 1003 | Completed | - |
| Myval™ Transcatheter Heart Valve Replacement | ||||
| LANDMARK 2 | Prospective, Sponsor Initiated, RCT | 690 | Recruitment ongoing | - |
| PROTAGORAS Trial | Prospective, Investigator Initiated | 954 | Recruitment ongoing | - |
| BOOST TAVR | Prospective, Investigator Initiated | 15 | Recruitment ongoing | - |
| Perisizing | Prospective, Investigator Initiated, RCT | 258 | Recruitment ongoing | - |
| XL anatomies | Prospective, Investigator Initiated, RCT | 480 | Recruitment ongoing | - |
| German Myval Series Registry | Prospective, Investigator Initiated, Single arm registry | 9 out of 2000 | Recruitment ongoing | - |
| PURE TAVI | Prospective, Investigator Initiated, RCT | 620 | Recruitment ongoing | - |
| Tri-match analysis | Retrospective, Investigator Initiated, matched pair comparision | 300 | Recruitment ongoing | - |
| LANDMARK – Lead-in cases | - | 82 out of 120 | Recruitment ongoing | - |
| START YOUNG | Prospective, Investigator Initiated, RCT | 1180 | Recruitment ongoing | - |
| TAX TAVR | Prospective, Investigator Initiated, Single arm registry | 1 out of 100 | Recruitment ongoing | - |
| MYLEAD | Prospective, Investigator Initiated, Single arm registry | 63 out of 500 | Recruitment ongoing | - |
| MARVEL | Prospective, Investigator Initiated, Single arm registry | 164 | Recruitment ongoing | - |
| MyPORTuVal | Prospective, Investigator Initiated, Single arm registry | 150 | Recruitment ongoing | - |
| Myval Inception | Prospective, Sponsor Initiated, Single arm registry | 200 | Recruitment ongoing | - |
| Mitral ViV Post CT | Ambispective, Investigator Initiated, Single arm registry | 68 | Recruitment ongoing | - |
| MATRIX | Prospective, randomized, multinational, non-inferiority trial | 604 | Recruitment ongoing | - |
| Myval L/XL RCT | Prospective, randomized, multinational, non-inferiority trial | 480 | Recruitment ongoing | - |
| Redo TAVR | Prospective Registry | 300 | Recruitment ongoing | - |
| OCTAPRO Registry | - | 175 | Recruitment ongoing | - |
| Mitral ViV Global Retrospective Registry | Retrospective, multi-national, single-arm, real-world study | 300 | Recruitment ongoing | - |
| BASELINE trial | Multi-center, RCT | 209 out of 440 | Recruitment ongoing | - |
| Myval Global Study | Retrospective, multi-national, multi-center study | 817 | Recruitment ongoing | - |
| Myval China | Prospective study | 107 out of 200 | Recruitment ongoing | - |
| LANDMARK trial- Randomised Cohort | Multicenter, RCT | 768 | Follow-up ongoing | - |
| LANDMARK trial- XL Nested Registry | LANDMARK trial- XL Nested Registry | 90 out of 100 | Recruitment ongoing | - |
| Compare TAVI | RCT | 1031 | Follow-up ongoing | - |
| AIIMS TAVI registry | Prospective study | 35 | Follow-up ongoing | - |
| MyVal-1 | Prospective, multi-center, single-arm, open-label study | 100 | Follow-up ongoing | - |
| Myval THV Registry | Retrospective study | 461 | Recruitment ongoing | - |
| 2 years FU observational registry | Multi-center, observational study | 207 | Completed | - |
| The SAPPHIRE prospective registry | Prospective, single-arm registry | 100 | Completed | - |
| The TRITON Study | Retrospective, multi-center registry | 122 | Completed | - |
| The EVAL registry | Retrospective, single-center study | 58 out of 166 | Completed | - |
| MATCH-BALL study | Prospective study | 130 out of 416 | Completed | - |
| The MYLAND Study | Retrospective, observational, multi-center study | 134 | Completed | - |
| The PANTHEON International Project | Retrospective study | 40 out of 69 | Completed | - |
| The OCTACOR India study | Multi-center, observational, real-world registry | 123 | Completed | - |
| Angiographic quantification of AR following Myval Octacor | Retrospective, core lab analysis | 125 | Completed | - |
| Commissural alignment with Myval THV | Prospective study | 10 | Completed | - |
| Myval single center experience with first 100 patients | Retrospective, single-center study | 100 | Completed | - |
| Myval Low-risk registry | Retrospective, multi-center registry | 100 | Completed | - |
| First experiences with a new balloon-expandable Myval transcatheter aortic valve: a preliminary study | Retrospective study | 25 | Completed | - |
| A central core lab analysis of conduction disturbances | Retrospective, central corelab analysis | 135 out of 1131 | Completed | - |
| Perimeter Sizing- a prospective pilot study | Prospective, single-center study | 60 | Completed | - |
| Short-term outcome after TAVR with Myval THV | Prospective, single-center study | 120 | Completed | - |
| TAVI: a report on Serbia’s first systematic program | Cohort study | 13 out of 56 | Completed | - |
| Myval Serbia: a single-center experience | Retrospective, single-center study | 13 | Completed | - |
| A propensity matched study | Retrospective, single-center study | 120 out of 223 | Completed | - |
| Single-center experience of 105 minimalistic TAVI patients | Retrospective, single-center study | 105 | Completed | - |
| Myval Iraq study | Prospective, single-center study | 100 | Completed | - |
| Myval intermediate-size | Retrospective survey | 1115 | Completed | - |
| TAVI for severe bicuspid aortic stenosis-2 years follow up experience from India | Multi-center study | 70 | Completed | - |
| Bicuspid study | Retrospective study | 68 | Completed | - |
| The XL study | Retrospective, observational, multi-center study | 10 | Completed | - |
| Myval NCAR | Multi-center, observational study | 113 | Completed | - |
| Quantitative angiographic assessment of AR after TAVI among three balloon-expandable valves | Retrospective, multi-center study | 108 out of 744 | Completed | - |
| Early and mid-term outcomes of MyVal TPVI | Multi-center, observational study | 53 | Completed | - |
| Myval in TPVI with pre-stented RVOT | Retrospective, multi-center study | 7 | Completed | - |
| Myval Mitral valve-in-valve: a retrospective study | Retrospective, observational, single-center study | 20 | Completed | - |
| Myval THV in ViV & ViR | Prospective, multi-center study | 97 | Completed | - |
| Myval in mitral valve-in-valve | Retrospective, multi-center study | 11 | Completed | - |
| Myval in Argentina | Prospective, multi-center registry | 300 | Completed | - |
| TheBE-PANTHEON internationalproject | Retrospective study | 41 out of 144 | Completed | - |
| Evermine 50™ Everolimus Eluting Coronary Stent System | ||||
| Sponsor Initiated Study | ||||
| SORT OUT XII Stent Trial | Prospective, Multicenter , RCT | 3150 (675,27) | Recruitment ongoing | - |
| SORT OUT XII DAPT Trial | Prospective, Multicenter , RCT | 3150 (675,27) | Recruitment ongoing | - |
| E-FIFTY OCT Study | Prospective, Multicenter , RCT | 62 | Recruitment ongoing | - |
| Evermine 50 EES-1 Study | Prospective study | 118 | Follow-up ongoing | Know More |
| Evermine 50 EES- KLES Study | Observational study | 171 | Completed | Know More |
| Evermine 50 EES- Retrospective Real-world Study | Real-world study | 65 out of 156 | Completed | Know More |
| Evermine 50 EES- Observational Study | Prospective study | 711 | Completed | Know More |
| Evermine 50 EES-1 BGM | Prospective, single-arm, single-center, post-marketing study | 251 | Completed | - |
| Metafor™ Sirolimus Eluting Coronary Stent System | ||||
| PRESUME study | Retrospective, observational, single-center, real-world study | 1318 out of 1600 | Recruitment ongoing | - |
| Twelve-month clinical outcomes of Metafor SES | Retrospective, observational, single-center study | 141 | Completed | - |
| Safety and performance of Metafor SES | Retrospective, non-randomized, single-center study | 127 | Completed | Know More |
| One-year clinical outcomes of Metafor SES in patients with CAD | Retrospective, observational, single-center, post-marketing study | 251 | Completed | Know More |
| Mozec™ Rx PTCA Balloon Dilation Catheter | ||||
| Sponsor Initiated Study | ||||
| Leave Nothing Behind | Prospective, Multicenter , RCT | 2256 | Recruitment ongoing | - |
| Mozec NC study | Retrospective, single-center, single-arm study | 57 of 140 | Completed | - |
| The Mozart registry | Prospective, non-randomized, single-arm registry | 41 | Completed | - |
| Mozec SEB PTCA-1 | Prospective study | 141 | Completed | Know More |
| NexGen™ Bare Metal Stent | ||||
| The Polish NexGen Registry | Prospective, multi-center registry | 383 | Completed | - |
| BioMime™ Morph Sirolimus Eluting Tapered Coronary Stent System | ||||
| Morph India Study | Prospective study | 448 | Follow-up ongoing | Know More |
| Morpheus Global Registry | Prospective, global registry | 565 | Completed | Know More |
| BioMime Morph BGM Study | Prospective study | 88 | Completed | Know More |
| Real-world experience with BioMime Morph | Retrospective, observational analysis | 88 | Completed | - |
| The OVERLONG Registry | Retrospective, observational, single-center study | 678 | Completed | - |
| One-year outcomes of BioMime Morph | Retrospective, observational, single-center study | 172 | Completed | - |
| Feasibility and outcomes of left main to branch vessel PCI with BioMime Morph: a real-world experience | Prospective, non-randomised, single-center study | 41 | Completed | - |
| Real-world experience with BioMime Morph in patients with long coronary artery stenosis | Prospective, observational, multi-center study | 272 | Completed | - |
| Clinical experience with 12-month follow-up in patients after implantation of BioMime Morph | Prospective clinical cohort study | 32 | Completed | - |
| Feasibility of implanting 50-60 mm-tapered drug eluting stents in CTO | Retrospective, single-arm study | 51 out of 54 | Completed | - |
| Comparing the clinical results of very long stents (≥40 mm) or overlapping stents in real clinical practice | Retrospective, observational, single-center study | 628 | Completed | - |
| Clinical outcomes of BioMime Morph in real-world patients with long diffused de novo coronary lesions | Retrospective, non-randomized, multi-center study | 362 | Completed | - |
| First report of the use of BioMime Morph for the treatment of CTO with the hybrid algorithm | Retrospective, observational study | 49 out of 100 | Follow-up ongoing | - |
| First experience with BioMime Morph in patients with diffuse long coronary lesions | Prospective, single-center study | 85 | Completed | - |
| MeRes100™ Sirolimus Eluting BioResorbable Vascular Scaffold System | ||||
| MeRes100 CIMS-CT study | Ambispective study | 17 out of 34 | Recruitment ongoing | - |
| RESET-1 | Prospective study | 7 out of 200 | Recruitment ongoing | - |
| MeRes100 IVUS Study | Prospective study, multi center | 88 | Recruitment ongoing | - |
| MeRes100 -CT Study | Ambispective study, single center | 15 out of 48 | Recruitment ongoing | - |
| The Promise Study | prospective,single arm Multicenter registry | 120 | Recruitment ongoing | - |
| MeRes100 Iberia | Prospective study, multi center | 150 | Recruitment ongoing | - |
| MeRes100 BRS Matched analysis | Retrospective study | 548 | Follow-up ongoing | - |
| MeRes-1 trial | Prospective, multi-center, single-arm, open-label study | 108 | Completed | Know More |
| MeRes-1 Extend trial | Prospective, multi-centre, single-arm, open-label study | 64 | Completed | Know More |
| BioMime Branch™ Sirolimus Eluting Coronary Side Branch Stent System | ||||
| BioMime Branch-1 Study | RCT | 101 out of 183 | Recruitment ongoing | - |
| BioMime Branch KEM registry | Prospective, single-center study | 69 | Recruitment ongoing | - |
| BioMime Branch Italy: A Single-Center Experience | Retrospective, single-center study | 58 | Completed | - |
| Menox™ Liquid Embolic System | ||||
| Serial Delivery of DMSO-Based Non-Adhesive Embolic Agents for Cerebral AVM Treatment | Prospective, single-center study | 16 | Completed | - |
| Initial Experience with Menox in Endovascular Treatment of Cerebral AVMs | Retrospective analysis of prospectively collected data | 24 | Completed | - |
| Comparison of a Novel Liquid Embolic System with Commonly Used Embolic Agents in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulas | Single center, retrospective study | 11 out of 19 | Completed | - |
| Product | ||||
| CREDENCE BtK-1 Study | Prospective, multi-center, open-label study | 30 | Completed | Know More |
| Obtura™ Vascular Closure Device | ||||
| Obtura VCD-1 Study | Prospective study | 268 | Completed | Know More |
| ORTHOPEDIC | ||||
| Freedom® Total Knee System | ||||
| Freedom TKA Registry | Multi-center, Retrospective study | 500 | Recruitment ongoing | Know More |
| Freedom 400 | Prospective, single-arm, post-marketing study | 449 | Follow-up ongoing | - |
| Mid-Term Outcomes of Bilateral TKA in Indian Patients: Impact of BMI | Prospective, observational, multi-center study | 190 | Completed | - |
| Age-wise Comparative Analysis of TKA: A Multicenter Indigenous Study | Prospective, multi-center, real-world study | 300 | Completed | - |
| BMI's Impact in Total Knee Arthroplasty: An Indian Perspective | Retrospective, multi-center study | 259 | Completed | - |
| 3D CT Templating in Predicting Implant Size and Alignment in Robot-Assisted TKA | Prospective, single-center study | 30 | Completed | - |
| Bone-Conserving High Flexion PS Total Knee System in Indian Population | Prospective study | 208 | Completed | - |
| Role of patient counselling after TKA in improving satisfaction rates | Prospective, randomized study | 200 | Completed | - |
| Femoral Condylar Restoration and Functional Outcomes: 5-Year Follow-Up Study | Prospective, single-center study | 172 | Completed | - |
| All-poly tibial Freedom® total knee system for treating osteoarthritis patients | Retrospective, single-center, post-marketing study | 158 | Completed | - |
| Opulent™ Total Knee System | ||||
| Opulent CR - Paras | Retrospective study | 531 | Recruitment ongoing | - |
| Opulent Knee CR - Sarvodaya | Retrospective study | 200 out of 500 | Recruitment ongoing | - |
| Latitud Total Hip Replacement System | ||||
| Latitud180 Study | Prospective, multi-center, observational, post-marketing surveillance study | 192 | Follow-up ongoing | Know More |
| Product | ||||
| Clinical and Radiological Outcomes in Robotic-Assisted Total Knee Arthroplasty | 22 | Completed | Know More | |
| ENDO-SURGERY | ||||
| MIRUS™ Disposable Hemorrhoids Stapler | ||||
| MIRUS™ Disposable Hemorrhoids Stapler | Prospective, single-arm study | 82 | Completed | Know More |
| Stapled Hemorrhoidopexy with Novel Three-Row Stapler: A Single-Center Experience | Retrospective, single-center, cohort study | 77 | Completed | - |
| Conventional vs stapled haemorrhoidectomy: three-years experience | Retrospective study | 150 | Completed | - |
| MIRUS™ Circular Stapler | ||||
| Three vs. Two Rows Circular Stapler for Stapled Hemorrhoidopexy | Retrospective, observational, cohort study | 224 | Completed | - |
| ABSOMESH™ Polyglecaprone 25/ Polypropylene Mesh | ||||
| Open vs laparoscopic repair in umbilical and para umbilical hernias | Prospective, observational study | 70 out of 156 | Completed | - |
| MERIZELLE™ Absorbable Hemostat | ||||
| MERIZELLE-1 | Prospective, multi-center, post-marketing surveillance study | 189 | Completed | Know More |
| Fiona™ Intrauterine Contraceptive Device | ||||
| Fiona-1 registry | Prospective, open-label, single-arm, post-marketing study | 309 out of 318 | Completed | Know More |
| ENT | ||||
| Mycs™ Eustachian Tube Balloon Dilatation Catheter system | ||||
| Mycs-RCT Trial | - | 104 | Recruitment ongoing | - |
| DIAGNOSTICS | ||||
| SURGICAL ROBOTS | ||||
| Product | ||||
| Clinical and Radiological Outcomes in Robotic-Assisted Total Knee Arthroplasty | 22 | Completed | Know More | |
| WHO PQ Products | ||||
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