NCT00855478
French Post-Marketing Surveillance Survey
Ran, enrolled patients, then stopped for a reason unrelated to the science — flagged as possibly worth a second look.
- Phase
- PHASE4
- Enrollment
- 4,080
- Sponsor class
- INDUSTRY
- Taxonomy code
- business_strategic
What the registry says
“Early termination of patient enrollment based on business decision”
What real verification found
NCT00855478 was a French Phase 4 post-marketing surveillance registry (not a hypothesis-testing trial — the CT.gov record explicitly says "there is no pre-specified endpoint") assessing real-world safety/efficacy of Cordis's Cypher and Cypher Select sirolimus-eluting coronary stents. It enrolled 4,080 patients before Cordis terminated enrollment in 2008 for a "business decision." No results were ever posted to CT.gov, and I found no dedicated publication of this specific French 4,080-patient cohort under any name (searched combinations of "French registry," "e-registry," "4080 patients," "Cypher," "Cordis," and the study's responsible-party physician Hans Peter Stoll — nothing came back). However, the underlying question this registry existed to answer — is the Cypher/Cypher Select sirolimus-eluting stent safe and effective in unselected, real-world practice — was already being answered, and was further answered, by much larger contemporaneous or overlapping efforts on the identical device: 1. The e-Cypher registry: an international web-based PMS registry of 15,157 patients across 279 centers in 41 countries (explicitly including France), with 1-year safety results published in Circulation in 2006 (Urban et al., "Safety of Coronary Sirolimus-Eluting Stents in Daily Clinical Practice," https://www.ahajournals.org/doi/10.1161/circulationaha.104.532242), plus country-specific follow-up papers (e.g., an Israeli-arm analysis in the American Journal of Cardiology). 2. The e-SELECT registry, another international multicenter PMS registry specifically for the Cypher Select variant, published in JACC: Cardiovascular Interventions in 2011 (PMID 22230152). 3. A separate US-PMS Cypher registry, also published (PMID 20124586). 4. Pre-approval randomized trials (SIRIUS, E-SIRIUS, C-SIRIUS) had already established Cypher's core safety/efficacy profile before any of these surveillance registries began. On top of that, the product itself became moot: Cordis announced in June 2011 that it was discontinuing the entire Cypher stent line and exiting the drug-eluting-stent market altogether (confirmed via tctmd.com), citing competitive/market-share reasons rather than safety. So even the general question this French survey was tracking stopped being a live commercial or clinical concern for Cordis within a few years of the 2008 termination. Net: the specific French cohort's data appears never separately published, but the safety/efficacy question it was designed to monitor was substantially and repeatedly answered by far larger multinational post-marketing registries on the same device (including French sites), and the device itself was withdrawn from the market in 2011 — so the question is moot rather than genuinely open.
Full search & fetch trail
WebSearch: "NCT00855478 French Post-Marketing Surveillance Survey Cordis"; "Cordis \"French Post-Marketing Surveillance Survey\" Cypher stent"; "Cordis Cypher stent French registry e-Cypher OR \"French registry\" sirolimus publication results 4080 patients"; "e-Cypher registry 15157 patients countries France safety sirolimus stent Urban Circulation 2006"; "Cypher stent France post-marketing surveillance 4080 patients pharmacovigilance"; "Stoll Cordis Cypher France registre postmarketing PubMed". WebFetch: https://clinicaltrials.gov/api/v2/studies/NCT00855478 (full study record, no results/publications listed); https://www.ahajournals.org/doi/10.1161/circulationaha.104.532242 (403 blocked, relied on search snippet instead); https://www.tctmd.com/news/cordis-announces-plans-discontinue-cypher-stents-drop-nevo-development (confirmed 2011 discontinuation and market-based reasons).