Figures cited from the live ClinicalTrials.gov record NCT03927560 and the published bioaccess® Brazil country page, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current ANVISA, CEP, and FDA rules with qualified advisers. We name only the hospital and trial that record supports. The overall status on the live file is UNKNOWN. bioaccess® is not listed on the NCT and no bioaccess® page claims this robotic-PCI study.
If you searched Hospital Israelita Albert Einstein clinical trial, Einstein São Paulo robotic PCI, Pedro Lemos robotic PCI Brazil, or “go direct to Einstein,” you followed a hospital that is the sponsor of a public device-procedure record. Hospital Israelita Albert Einstein in São Paulo is a real tertiary site. It is not the CRO for your investigational device.
bioaccess®’s position is simple and it is not adversarial: Einstein is the site (and, on this NCT, the academic sponsor). The First-in-Human CRO still owns ANVISA / CEP when the investigation is yours, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus Colombia if that is the better file. A hospital-sponsored robotic-PCI protocol does not make Einstein the vendor for a U.S. startup’s next implant.
This page does not clone clinical trials in Brazil. That page stays the country system. This page answers the hospital-named query.
What NCT03927560 actually says (live 23 August 2026)
NCT03927560 — brief title: Robotic-Assisted Percutaneous Coronary Intervention. Official title: a safety and effectiveness study applied to the Brazilian public health system. Organization study ID: Robotic First. Lead sponsor: Hospital Israelita Albert Einstein (class OTHER). Status: UNKNOWN. Estimated start 10 June 2019; estimated completion 10 March 2020; estimated enrollment 83; interventional, single-group, no masking; intervention: robotic-assisted percutaneous coronary intervention; condition: coronary artery disease. Brief summary: PCI is safe but fully operator-dependent and associated with radiation exposure; this study will evaluate robotic-assisted PCI as an alternative to manual operation. Primary outcomes listed: procedure complications and procedure success.
Key inclusion on the record: age ≥ 18; symptomatic ischemic heart disease and/or objective ischemia; elective (non-urgent) PCI; obstructive target lesion(s) > 50% by visual analysis; interventional plan includes robotic manipulation in at least one treatment as judged by the operator; acceptable surgical-revascularization candidate. Key exclusions include STEMI in the prior 48 hours, LVEF < 30%, and creatinine > 2.0 mg/dL or CrCl < 30 ml/min.
The live record lists no facility rows. The hospital appears as sponsor. Central contact: Pedro Lemos, PhD, phone +55 (11) 2151-4306, email pedro.lemos@einstein.br on the public file. No overall official is listed. We will not invent a cath-lab address the NCT omitted, and we will not upgrade UNKNOWN to completed or recruiting.
Read the record as it is: an Einstein-sponsored robotic-PCI safety and effectiveness study aimed at the Brazilian public health system, with 2019–2020 estimated dates and an unknown current status. It is not a first-in-human of a new coronary implant, and it is not a bioaccess® case study.
A hospital sponsor is still not your CRO
Academic hospitals sponsor their own procedure-innovation protocols. That is normal. It does not transfer ANVISA, import, or 812.28 ownership to a U.S. company that later emails the same contact because Google surfaced “Einstein robotic PCI.”
What Einstein can typically do when a sponsor “goes direct”:
- Discuss whether a service line — here, a public contact associated with robotic PCI — has interest and capacity for your protocol, which is not automatic.
- Share institutional CEP calendars and hospital research rules.
- Quote procedure, bed, and local staffing costs for cases they will physically run.
What the hospital is not built to own for your investigational device:
- ANVISA under RDC 837/2023 when your device — not their robotic-PCI technique protocol — is the investigational article.
- CEP packet writing, deficiency cycles, and the Law 14874 clock as a managed workstream.
- Investigational import and accountability — importer of record.
- ISO 14155 monitoring, EDC, SAE, TMF designed for a later FDA file.
- 21 CFR 812.28 eligibility package. See OUS FIH and FDA IDE.
- Country optionality. If Einstein is the wrong room, InCor, Dante Pazzanese, or a Colombian site will not appear on an Einstein MSA.
Site versus CRO
| Workstream | What Einstein typically owns | What the CRO still owns |
|---|---|---|
| PCI / robotic capability | Cath lab, imaging, operators, hospital quality | Feasibility of your device protocol, training, accountability |
| Ethics | Institutional CEP calendar | Packet, ICF, IB alignment |
| National authority | Hospital-sponsored filings for hospital-sponsored work | ANVISA dossier when you are the commercial sponsor of an investigational device |
| Import | Receiving dock if contracted | Importer of record |
| Quality | The case and hospital quality system | ISO 14155 monitoring, EDC, SAE, TMF |
| FDA conversation | Source documents from cases they run | 21 CFR 812.28 narrative |
| Country optionality | One São Paulo hospital | The bioaccess® platform, including Colombia |
ANVISA in one screen
Published on the Brazil country page: 6–10 weeks ethics + ANVISA; $20,000–$35,000 per patient; 15+ pre-qualified sites; WHO-listed authority; trial authorization is not market registration. Do not treat those figures as an Einstein-only quote, and do not treat an UNKNOWN 2019 protocol as a current clock.
Do not confuse Einstein with InCor or Dante Pazzanese
Googling “São Paulo device trial” will surface all three. InCor is the recruiting Cephea South America site (PI Alexandre Abizaid) and the terminated Leaflex facility. Dante Pazzanese holds the 1999–2005 sirolimus FIM and the recruiting VANGUARD AVR comparison. Einstein holds a hospital-sponsored robotic-PCI record whose status is UNKNOWN and which lists no facility row. Use the intercept that matches the NCT you actually opened. If you do not have an NCT yet, start with country fit on clinical-trials-brazil and CRO in Colombia, then let the CRO name the building.
Colombia is still on the map
bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. A São Paulo private-hospital search is not an instruction to abandon INVIMA. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.
Frequently asked questions
Can I contract Hospital Israelita Albert Einstein directly?
You can try. The hospital can discuss interest and CEP calendars. It cannot become your ANVISA applicant, importer, insurer, ISO 14155 monitor, or 812.28 packager because it sponsored a robotic-PCI record. Contract the CRO; let the CRO activate Einstein — or another São Paulo or Colombian site — as the site.
Did bioaccess® run NCT03927560?
No public bioaccess® page says so. We will not invent that claim.
Is this first-in-human?
The record is a safety and effectiveness study of robotic-assisted PCI in the Brazilian public-health framing. We will not relabel it FIH. Use this page because sponsors Google the hospital for device trials, not because we are inflating the design.
The status is UNKNOWN. Why write a page?
Because the hospital name still ranks. Honesty about UNKNOWN is the intercept. We will not pretend the study is recruiting or completed.
If I already have Einstein, what does the CRO still do?
Regulatory-fit; ANVISA / CEP for your device; insurance; import; activation; ISO 14155; 812.28; optionality versus InCor, Dante Pazzanese, or Colombia.
Does googling Einstein mean I should avoid the hospital?
No. Do not smear Albert Einstein. The error is treating a hospital sponsor as your CRO.
Next step
Contact bioaccess® · First-in-Human CRO · Brazil · CT.gov hub · InCor · Dante Pazzanese · CRO in Colombia.
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