Figures cited from live ClinicalTrials.gov records NCT00233792 and NCT06688448 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 institute and trials those records support. The 1999–2005 sirolimus FIM is historic — we say so. bioaccess® is not listed on either NCT and no bioaccess® page claims these studies.
If you searched Dante Pazzanese first-in-man, Instituto Dante Pazzanese clinical trial, sirolimus stent Brazil FIM, or “go direct to Pazzanese,” you followed a facility name ClinicalTrials.gov published. Instituto Dante Pazzanese de Cardiologia in São Paulo is a real tertiary cardiology site. It is not the operator of today’s ANVISA file.
bioaccess®’s position is simple and it is not adversarial: Dante Pazzanese is the site. The First-in-Human CRO still owns ANVISA / CEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus Colombia if INVIMA is the better next file. Sponsors who skip the CRO and email the institute still have to rebuild that stack. A historic first-in-man plaque does not make the hospital a CRO.
This page does not clone clinical trials in Brazil. That page stays the country system. This page answers the institute-named query.
What the public NCT file actually says
NCT00233792 — brief title: FIM-BR – First-in-Man Study (Brazil Part) With Sirolimus-Coated BX VELOCITY Stent. Official title: evaluation of the sirolimus-coated modified BX VELOCITY balloon-expandable stent in de novo or restenotic native coronary lesions. Lead sponsor: Cordis US Corp. Status: COMPLETED. Start listed December 1999; actual completion March 2005; actual enrollment 30; phases 1 and 2; single-center, non-randomized; interventions: sirolimus-coated Bx VELOCITY, fast-release and slow-release, on the Raptor OTW delivery system; repeat angiography at four months; twelve-month follow-up. Facility: Instituto Dante Pazzanese of Cardiology, São Paulo, Brazil. Principal investigator on the record: Eduardo J Sousa, MD. This is a genuine historic first-in-man program. It is also more than twenty years old. Treat it as history, not as a 2026 startup clock.
NCT06688448 — VANGUARD, “Valvular Assessment of New Generation Aortic Replacement Devices.” Official title: comparative efficacy and durability of next-generation biological aortic prostheses. Lead sponsor: Instituto Dante Pazzanese de Cardiologia (other/academic). Status: RECRUITING. Actual start 1 December 2024; estimated completion 1 December 2036; estimated enrollment 200; ages 18–65; randomized, open-label, parallel, single-center AVR. Interventions: Dafodil® prosthesis and INSPIRIS Resilia® (the record also writes “Inspires Resilia”). Primary outcome: rate of bioprosthetic valve deterioration. The detailed description states the trial is conducted at a tertiary cardiology hospital of the Brazilian Unified Health System (SUS); Fundação Adib Jatene is named as a resource; device supply is supported by Meril Life Sciences and Edwards Lifesciences. Location: Instituto Dante Pazzanese de Cardiologia, São Paulo, RECRUITING, with named contacts Tacianne Rolemberg Delamain and Patrícia Paiva / Patricia Paiva. This is a hospital-sponsored comparison of two commercial-generation bioprostheses. It is not a first-in-human of an unapproved startup valve, and we will not market it as one.
Neither record names bioaccess®. That is how a sponsor finds Dante Pazzanese without finding the operator for a new investigational device.
Historic FIM is not today’s operator layer
Eduardo Sousa’s sirolimus FIM is part of interventional cardiology’s public memory. It is fair to say the institute has run first-in-man coronary work. It is not fair to tell a 2026 board that “Pazzanese already knows how to file ANVISA, import an investigational TMVR, monitor to ISO 14155, and package 21 CFR 812.28 because they did a Cordis stent in 1999.” Those workstreams have been rewritten — RDC 837/2023, Law 14874, importer-of-record practice, and FDA’s foreign-data rule among them.
VANGUARD shows the other trap: a recruiting, hospital-sponsored surgical-valve RCT can look like “the hospital is already running devices.” It is running its comparison of Dafodil and INSPIRIS inside SUS. Your unapproved device is a different contract, a different dossier, and usually a different import.
Site versus CRO
| Workstream | What Dante Pazzanese typically owns | What the CRO still owns |
|---|---|---|
| Cardiac capability | Cath lab, OR, imaging, implanting physicians, SUS tertiary infrastructure | Protocol feasibility, training, investigational-device accountability |
| Ethics | Institutional CEP calendar | Packet, ICF, IB alignment |
| National authority | Not a hallway conversation, even after a famous FIM | ANVISA RDC 837/2023 dossier when the study is a clinical investigation of your device |
| Import | Receiving dock if contracted | Importer of record — LATAM import page |
| Quality | Hospital quality and the case | ISO 14155 monitoring, EDC, SAE, TMF |
| FDA conversation | Source documents from cases they run | 21 CFR 812.28 narrative — eligibility, not clearance. OUS FIH and FDA IDE |
| Country optionality | One São Paulo institute | InCor, Einstein, Colombia, Panama if the indication needs them |
ANVISA in one screen
Published on the Brazil country page: ethics + ANVISA typically 6–10 weeks; CEP review capped at 30 business days under Law 14874; per-patient $20,000–$35,000; 15+ pre-qualified sites; trial authorization ≠ RDC 751/2022 market registration. Those are country figures, not a Pazzanese quote.
Do not confuse three São Paulo cardiology brands
InCor (HCFMUSP) is the Cephea / Leaflex facility. Hospital Israelita Albert Einstein is the sponsor of an UNKNOWN robotic-PCI record. Dante Pazzanese is the historic Cordis FIM institute and the VANGUARD AVR site. They are all in São Paulo and they are not interchangeable. A sponsor who emails “the São Paulo heart hospital” has not selected a site. bioaccess®’s job is to pick the room after the regulatory-fit review — and to keep Colombia on the table when INVIMA is the cleaner file — not to flatten three NCT brands into one hallway.
We will also not assign PercAssist, PAVmed, ReGelTec, or Mitralign to Dante Pazzanese. Those names remain country-level or unsourced at hospital level on the press hub.
Colombia is still on the map
bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. A 1999 São Paulo FIM is not a reason to leave INVIMA. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.
Frequently asked questions
Can I contract Dante Pazzanese directly?
You can try. The institute can discuss investigator interest, CEP calendars, and procedure costs. It cannot become your ANVISA applicant, importer, insurer, ISO 14155 monitor, or 812.28 packager because Cordis ran a FIM there a generation ago. Contract the CRO; let the CRO activate the site.
Did bioaccess® run the sirolimus FIM or VANGUARD?
No. We will not invent that claim. Named bioaccess® hospital-level FIH remains on the Panama Clinic, Santa Fe, and Asunción intercepts and their source case-study pages.
Is VANGUARD first-in-human?
Not as labeled. It is a recruiting randomized comparison of two named bioprostheses, hospital-sponsored, with industry device supply. Use it as evidence the institute is active in surgical valves — not as your startup’s FIH template.
If I already have the institute name, what does the CRO still do?
Regulatory-fit; ANVISA / CEP; insurance; import; activation; ISO 14155; 812.28; the option to use InCor or a Colombian site instead of or besides Pazzanese.
Does googling the historic FIM mean I should avoid the institute?
No. Do not smear Dante Pazzanese. The error is treating a 1999–2005 first-in-man as the 2026 CRO.
Next step
Contact bioaccess® · First-in-Human CRO · Brazil · CT.gov hub · InCor · Albert Einstein · CRO in Colombia.
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