Figures cited from the live ClinicalTrials.gov record NCT06152341 (last update posted 31 August 2026; first posted 30 November 2023) and the published bioaccess® Dominican Republic country page, verified 3 September 2026. General information, not legal or regulatory advice. Confirm current DIGEMAPS, CONABIOS, and FDA rules with qualified advisers. We name only the facility and the trial those sources support. No principal investigator is named on this NCT location row; we will not invent one. Akura Medical is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.
If you searched Centro de Intervenciones Cardiovasculares clinical trial, CIC Santiago de los Caballeros, Akura Medical ATC System, pulmonary embolism thrombectomy Dominican Republic, or “go direct to the Santiago site,” you followed a facility string ClinicalTrials.gov still publishes on 31 August 2026. Centro de Intervenciones Cardiovasculares in Santiago de los Caballeros, Santiago Province, is a real named cardiovascular facility on that record. It is not the operator of the DIGEMAPS file.
bioaccess®’s position is simple and it is not adversarial: Centro de Intervenciones Cardiovasculares is the site. The First-in-Human CRO still owns DIGEMAPS, CONABIOS-overseen ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia, Panama, or another Latin American country if Santiago is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row does not become a CRO.
This page is the intercept for the Santiago de los Caballeros query. It does not clone clinical trials in the Dominican Republic. That page stays the country operating system. Sister Dominican intercepts stay on their own buildings: Laser Center Santo Domingo, Instituto Espaillat Cabral, and Clínica Canela La Romana. Santiago de los Caballeros is a different city from Santo Domingo and from La Romana. Do not merge the slugs. The two São Paulo rows on the same NCT already have their own intercepts: Instituto Dante Pazzanese and InCor HCFMUSP.
Why the hospital name wins the search — and why that is not a CRO
NCT06152341 is an industry device listing. Brief title: Safety and Effectiveness of the ATC System in the Treatment of Acute PE. Official title: Safety and Effectiveness of the ATC System in the Treatment of Acute Pulmonary Embolism. Organization study ID: CP-60003. Lead sponsor: Akura Medical, class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed. The record publishes no central contact and no overall official.
Design on the 3 September 2026 snapshot: interventional; prospective, single-arm, multicenter; no masking; primary purpose treatment; phase N/A; estimated enrollment 30. Actual start 15 May 2024; estimated primary completion April 2027; estimated completion May 2027. Study first posted 30 November 2023; last update posted 31 August 2026. Condition: acute pulmonary embolism.
Status on that snapshot is SUSPENDED. The registry’s own reason, quoted as published: enrollment is temporarily paused pending device resupply to sites; enrollment is expected to resume to reach the target sample size following a recently approved protocol amendment; and the pause is not related to subject safety or device performance. We report that as written and add nothing to it.
Intervention, in the registry’s words: a device — the ATC System, designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE. The oversight module records the study as an FDA-regulated device study of an unapproved device that is a U.S. export. An unapproved, exported thrombectomy system running at 30 patients across three Latin American buildings is a CRO file, not a hospital favour.
The three location rows currently published:
- Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil — already intercepted.
- Instituto do Coracao (InCor), São Paulo, Brazil — already intercepted.
- Centro de Intervenciones Cardiovasculares, Santiago de los Caballeros, Santiago Province, Dominican Republic — this page. No principal investigator, contact, or row-level status is published for it.
Read the record as it is. Two Brazilian cardiology institutes had public intercepts and the Dominican row did not, even though it is the only Caribbean building on an unapproved-device PE study. That is the site-direct leak: a sponsor searching Akura, ATC System, or Santiago de los Caballeros interventional cardiology lands on a named hospital with no operator in the public copy.
Santiago de los Caballeros is a site. The CRO is the operator.
A Dominican interventional-cardiology centre can provide cath-lab time, a PE response pathway, imaging, and operators who do pulmonary-artery work. That is necessary. It is not sufficient for an unapproved, U.S.-exported thrombectomy system a sponsor expects to defend to a U.S. board later.
What a site can typically do when a sponsor “goes direct”:
- Discuss investigator interest and procedural feasibility for a PE protocol — when that service is available and appropriate for your device, which is not automatic.
- Share institutional Research Ethics Committee calendars and hospital research rules.
- Quote procedure, bed, and local staffing costs for the cases they will physically run.
What the site is not built to own for an investigational device:
- DIGEMAPS. The Ministry of Public Health, through the Dirección General de Medicamentos, Alimentos y Productos Sanitarios, is the national authority for health products including medical devices. A cath-lab conversation is not that submission.
- CONABIOS-overseen ethics. The Consejo Nacional de Bioética en Salud oversees Research Ethics Committees; institutional REC review is tied to the host institution once the site is chosen.
- Investigational import. A separate permit from the trial authorization and from a later commercial DIGEMAPS registration. The live importer-of-record guide already records DIGEMAPS as created by Decreto 82-15 (2015), with registration and import rules in Decreto 246-06. See importer of record for clinical trial devices in Latin America.
- Clinical trial insurance. Required. We will not invent a Santiago-only premium here.
- ISO 14155 monitoring, EDC, SAE reporting, and the TMF — including across the two São Paulo rows on the same NCT.
- The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after the GCP and ethics documentation that rule defines. Eligibility is not clearance. See OUS FIH and FDA IDE.
- Multi-country optionality. A suspended-for-resupply study is precisely when a single-hospital MSA stops stretching.
Going direct to Centro de Intervenciones Cardiovasculares is how you confirm a cath lab. It is not how you open an investigational file.
Site versus CRO
| Workstream | What the Santiago centre (site) typically owns | What the CRO still owns |
|---|---|---|
| Procedure | Cath lab, PE pathway, imaging, local staff | Protocol fit, training, device accountability and resupply logistics |
| Ethics | Institutional REC calendar and local rules | Packet, ICF, IB alignment, deficiency cycle under CONABIOS oversight |
| National authority | Not the permit holder by being listed on an NCT | DIGEMAPS clinical-trial file |
| Import | Receiving and storage if contracted | Importer of record for an unapproved, U.S.-exported system |
| 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 |
| Country optionality | One Santiago building (plus two São Paulo rows on the same NCT) | Colombia (INVIMA), Panama, and the rest of the bioaccess® platform |
How DIGEMAPS and CONABIOS sit next to the hospital
Use clinical trials in the Dominican Republic for the full pathway. Facts a sponsor searching this hospital needs on one screen, already published there and not re-averaged here:
- Institutional REC review averages ~30 days; CONABIOS-level review averages ~45 days, up to 120 depending on complexity.
- DIGEMAPS is the national regulatory authority for health products including medical devices; CONABIOS oversees Research Ethics Committees.
- Protocols follow the Declaration of Helsinki and the CIOMS international ethical guidelines. The submission package is in Spanish.
- The country hub publishes ~30% lower program cost than a comparable U.S. or EU program — an experience-based estimate from work since 2010, not a formal study.
- Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review when the investigation meets that rule’s GCP conditions. Eligibility is not clearance or approval.
- A commercial DIGEMAPS registration is a second, separate file from a clinical-trial authorization.
We will not invent a Santiago-only day count. Ask for a protocol-specific calendar. A hospital email is not a DIGEMAPS authorization.
What the Akura public file actually supports — and what it does not
- Device: the ATC System for mechanical removal of emboli in acute pulmonary embolism, as described on NCT06152341.
- Sponsor: Akura Medical (industry). No collaborator. No CRO named.
- Sites: Instituto Dante Pazzanese and Instituto do Coracao, São Paulo (existing intercepts); Centro de Intervenciones Cardiovasculares, Santiago de los Caballeros (this page).
- Design: prospective single-arm multicenter, phase N/A, estimated n=30, actual start 15 May 2024.
- Status: SUSPENDED — enrollment paused pending device resupply, expected to resume after an approved protocol amendment; the registry states the pause is not related to subject safety or device performance.
- Regulatory flags on the record: FDA-regulated device; unapproved device; U.S. export.
- Not claimed here: that the NCT named bioaccess®; that Akura Medical is a bioaccess® client; that we have ATC outcomes; that a named investigator exists on this row when the registry prints none; that Santiago de los Caballeros is the same building as Santo Domingo or La Romana.
What the CRO still does after you have a hospital name
- Regulatory-fit, not tourism. The Dominican Republic is a lead first-in-human jurisdiction on the published platform. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
- Protocol, IB, ICF, insurance, and the DIGEMAPS / CONABIOS packet — in Spanish.
- Importer of record and device accountability, including resupply across activated rows.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
- Optionality when one Caribbean cath lab is not enough.
The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™. Background: ClinicalTrials.gov FIH sites vs the CRO.
Frequently asked questions
Can I contract Centro de Intervenciones Cardiovasculares directly?
You can try. The facility can discuss investigator interest, local procedure costs, and REC calendars. It cannot become your DIGEMAPS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Akura listed Santiago on a registry row. Contract the CRO; let the CRO activate the site.
Did bioaccess® run the Akura ATC study?
No public bioaccess® page says so. We will not invent that claim. This page intercepts the search; it does not claim the study.
The study is SUSPENDED. Is that a safety problem?
The registry says no. Its stated reason is a temporary enrollment pause pending device resupply to sites, with enrollment expected to resume after an approved protocol amendment, and it explicitly states the pause is not related to subject safety or device performance. We quote that; we do not reinterpret it. Resupply across three countries is, however, exactly the import-and-accountability workstream a site does not own.
Who is the principal investigator in Santiago de los Caballeros?
The registry does not name one on this location row, and neither will we.
Is Colombia still an option?
Yes. bioaccess® still runs trials in Colombia. A Dominican search is not an instruction to abandon INVIMA. See CRO in Colombia.
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