--- title: ION US Post-Approval Study nct_id: NCT01422889 overall_status: COMPLETED sponsor: Boston Scientific Corporation study_type: OBSERVATIONAL primary_condition: Atherosclerosis countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01422889.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01422889" ct_last_update_post_date: 2016-02-04 last_seen_at: "2026-05-12T06:03:17.285Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # ION US Post-Approval Study **Official Title:** A U.S. Post-Approval Study of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System **NCT ID:** [NCT01422889](https://clinicaltrials.gov/study/NCT01422889) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 1120 - **Lead Sponsor:** Boston Scientific Corporation - **Conditions:** Atherosclerosis, Coronary Artery Disease - **Start Date:** 2011-09 - **Completion Date:** 2015-02 - **CT.gov Last Update:** 2016-02-04 ## Brief Summary The purpose of this study is to compile real-world clinical outcomes data for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. ## Detailed Description The ION™ stent is the third-generation Boston Scientific (BSC) paclitaxel-eluting coronary stent. It is designed for improved performance specific to deliverability and radio-opacity while maintaining a similar drug release profile of the TAXUS Express and TAXUS Liberté stents. Following PMA approval from the FDA for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System the ION US Post-Approval study will compile real-world clinical outcomes data for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Post-approval studies of drug-eluting stents (DES) provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 110 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: Consented subjects receiving one or more ION(TM)Coronary Stents Exclusion Criteria: Subjects not clinically indicated to receive an ION (TM)Coronary Stent ``` ## Arms - **ION Registry** — The ION Registry population was designed to collect real world safety and clinical outcomes data. There were 1120 subjects were enrolled, however 9 subjects did not receive a study stent therefore 1111 subjects were eligible for follow up. ## Interventions - **ION™ Coronary Stent System** (DEVICE) — This study is intended to evaluate the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System across a range of institutions and physician users to observe and assess subject outcomes and technology performance in a real-world setting. ## Primary Outcomes - **Cardiac Death or Myocardial Infarction (CD/MI)** _(time frame: 12 Months)_ — Cardiac Death or myocardial infarction (CD/MI) in the ION registry population. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations. ## Secondary Outcomes - **Stent Thrombosis** _(time frame: Annually, after the first year, through 2 years.)_ ## Locations (40) - NEA Baptist Memorial Hospital, Jonesboro, Arkansas, United States - St. Bernard's Medical Center, Jonesboro, Arkansas, United States - Bakersfield Memorial Hospital, Bakersfield, California, United States - Alvarado Hospital, San Diego, California, United States - Northside Hospital and Heart Institute, St. Petersburg, Florida, United States - University Community Hospital, Tampa, Florida, United States - Redmond Regional Medical Center, Rome, Georgia, United States - Kootenai Medical Center, Coeur d'Alene, Idaho, United States - Krannert Institute of Cardiology, Indianapolis, Indiana, United States - Indiana Heart Hospital, Indianapolis, Indiana, United States - Iowa Heart Center, West Des Moines, Iowa, United States - King's Daughters Medical Center - Kentucky Heart Inst, Ashland, Kentucky, United States - Maine Medical Center, Portland, Maine, United States - Union Memorial Hospital, Baltimore, Maryland, United States - Tufts Medical Center, Boston, Massachusetts, United States - Sparrow Health System - Sparrow Hospital, Lansing, Michigan, United States - Northern Michigan Hospital, Petoskey, Michigan, United States - Lakeland Hospitals at St. Joseph, Saint Joseph, Michigan, United States - Memorial Hospital at Gulfport, Gulfport, Mississippi, United States - Freeman West Hospital, Joplin, Missouri, United States - Our Lady of Lourdes Medical Center, Haddon Heights, New Jersey, United States - Jersey Shore University Medical Center, Sea Girt, New Jersey, United States - St. Joseph's Hospital Health Center, Liverpool, New York, United States - St. Elizabeth Medical Center, Utica, New York, United States - Wake Medical Center, Raleigh, North Carolina, United States - Ohio State University Medical Center, Columbus, Ohio, United States - Riverside Methodist Hospital, Columbus, Ohio, United States - Mercy St. Vincent Medical Center, Toledo, Ohio, United States - Oklahoma Heart Hospital, Oklahoma City, Oklahoma, United States - St. Mary Medical Center, Yardley, Pennsylvania, United States - Sisters of Charity Providence Hospital, Columbia, South Carolina, United States - Grand Strand Regional Medical Center, Myrtle Beach, South Carolina, United States - Regional Hospital, Jackson, Tennessee, United States - Centennial Medical Center, Nashville, Tennessee, United States - Baylor Heart & Vascular Hospital, Dallas, Texas, United States - CRSTI/Medical City Dallas, Dallas, Texas, United States - Kingwood Medical Center Hospital, Kingwood, Texas, United States - Methodist Texsan Hospital, San Antonio, Texas, United States - Meriter Hospital, Inc., Madison, Wisconsin, United States - CaRE Foundation, Inc., Wausau, Wisconsin, United States ## Recent Field Changes (last 30 days) - `locations.nea baptist memorial hospital|jonesboro|arkansas|united states` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.st. bernard's medical center|jonesboro|arkansas|united states` — added _(2026-05-12)_ - `locations.bakersfield memorial hospital|bakersfield|california|united states` — added _(2026-05-12)_ - `locations.alvarado hospital|san diego|california|united states` — added _(2026-05-12)_ - `locations.northside hospital and heart institute|st. petersburg|florida|united states` — added _(2026-05-12)_ - `locations.university community hospital|tampa|florida|united states` — added _(2026-05-12)_ - `locations.redmond regional medical center|rome|georgia|united states` — added _(2026-05-12)_ - `locations.kootenai medical center|coeur d'alene|idaho|united states` — added _(2026-05-12)_ - `locations.krannert institute of cardiology|indianapolis|indiana|united states` — added _(2026-05-12)_ - `locations.indiana heart hospital|indianapolis|indiana|united states` — added _(2026-05-12)_ - `locations.iowa heart center|west des moines|iowa|united states` — added _(2026-05-12)_ - `locations.king's daughters medical center - kentucky heart inst|ashland|kentucky|united states` — added _(2026-05-12)_ - `locations.maine medical center|portland|maine|united states` — added _(2026-05-12)_ - `locations.union memorial hospital|baltimore|maryland|united states` — added _(2026-05-12)_ - `locations.tufts medical center|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.sparrow health system - sparrow hospital|lansing|michigan|united states` — added _(2026-05-12)_ - `locations.northern michigan hospital|petoskey|michigan|united states` — added _(2026-05-12)_ - `locations.lakeland hospitals at st. joseph|saint joseph|michigan|united states` — added _(2026-05-12)_ - `locations.memorial hospital at gulfport|gulfport|mississippi|united states` — added _(2026-05-12)_ - `locations.freeman west hospital|joplin|missouri|united states` — added _(2026-05-12)_ - `locations.our lady of lourdes medical center|haddon heights|new jersey|united states` — added _(2026-05-12)_ - `locations.jersey shore university medical center|sea girt|new jersey|united states` — added _(2026-05-12)_ - `locations.st. joseph's hospital health center|liverpool|new york|united states` — added _(2026-05-12)_ - `locations.st. elizabeth medical center|utica|new york|united states` — added _(2026-05-12)_ - `locations.wake medical center|raleigh|north carolina|united states` — added _(2026-05-12)_ - `locations.ohio state university medical center|columbus|ohio|united states` — added _(2026-05-12)_ - `locations.riverside methodist hospital|columbus|ohio|united states` — added _(2026-05-12)_ - `locations.mercy st. vincent medical center|toledo|ohio|united states` — added _(2026-05-12)_ - `locations.oklahoma heart hospital|oklahoma city|oklahoma|united states` — added _(2026-05-12)_ - `locations.st. mary medical center|yardley|pennsylvania|united states` — added _(2026-05-12)_ - `locations.sisters of charity providence hospital|columbia|south carolina|united states` — added _(2026-05-12)_ - `locations.grand strand regional medical center|myrtle beach|south carolina|united states` — added _(2026-05-12)_ - `locations.regional hospital|jackson|tennessee|united states` — added _(2026-05-12)_ - `locations.centennial medical center|nashville|tennessee|united states` — added _(2026-05-12)_ - `locations.baylor heart & vascular hospital|dallas|texas|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01422889.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01422889* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*