The new Center for Devices and Radiological Health (CDRH) Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
On January 1, 2005, the oversight responsibility was transferred to CDRH's Office of Surveillance and Biometrics (OSB) and the PAS review functions were integrated into the medical device epidemiology program. Guidance on report format and content was developed to ensure optimal PAS reporting and review. http://www.fda.gov/cdrh/osb/guidance/1561.html.
CDRH has established a new automated tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner. The effective tracking system is based on study timelines incorporated in study protocols and agreed upon by the CDRH and manufacturer.
In addition to this internal tracking system, CDRH launched this publicly available webpage to keep all stakeholders informed of their progress. It displays not only the report status, but also study status (based on protocol-driven timelines) of each PAS.
1. YOU HAVE AGREED TO CONDUCT THE FOLLOWING STUDIES AND TO REPORT ON THESE STUDIES EVERY
6 MONTHS FOLLOWING PMA APPROVAL UNTIL COMPLETION OF THE STUDIES: YOU HAVE AGREED TO PERFORM A LONG-TERM FOLLOW-UP STUDY ON AT LEAST 305 PATIENTS. THE GOALS OF THIS FOLLOW-UP STUDY ARE TO EVALUATE THE LONGER-TERM SAFETY AND EFFECTIVENESS OF THE XACT CAROTID STENT SYSTEM AND EMBOSHIELD? EMBOLIC PROTECTION SYSTEM THROUGH THREE YEARS OF IMPLANTATION. AT EACH ANNUAL VISIT, A CLINICAL EXAMINATION, A CAROTID DUPLEX ULTRASOUND, AND A NEUROLOGICAL EXAM (NIHSS) WILL BE CONDUCTED. CLINICAL DATA WILL BE RECORDED ON THE CORRESPONDING CASE REPORT FORMS (CRFS). DIAGNOSTIC STUDIES ON PATIENTS IN THIS COHORT WILL CONTINUE TO BE EVALUATED BY THE CORE LABORATORY. ALL DATA WILL BE MONITORED, ENTERED INTO A DATABASE, ANALYZED AND SUBMITTED IN REPORTS TO THE FDA AND A FINAL REPORT WILL BE SUBMITTED AFTER COMPLETION OF THE FOLLOW-UP AND ANALYSIS. THIS FOLLOW-UP PROPOSAL WILL ALLOW AN EVALUATION OF ADVERSE EVENTS, NEUROLOGICAL EVENTS, AND PERCENT STENOSIS. YOU HAVE AGREED TO CONDUCT A POST-APPROVAL STUDY(IES) THAT INCLUDES AT LEAST 1500 SEQUENTIALLY ENROLLED PATIENTS FROM UP TO 150 GEOGRAPHICALLY DISBURSED SITES. THIS STUDY WILL FOLLOW ALL 1500 PATIENTS FOR 30 DAYS, AND 500 PATIENTS OUT TO 12 MONTHS. THE POST-APPROVAL STUDY WILL ENROLL PATIENTS FROM HIGH, MODERATE AND LOW VOLUME CENTERS AND TREATED BY PHYSICIANS THAT REPRESENT GROUP 1, 2, AND 3 TRAINING. IMAGING DATA, THAT IS, FOLLOW-UP ULTRASOUND OR ANGIOGRAPHIC ASSESSMENTS, WHEN PERFORMED, WILL BE REVIEWED BY A CORE LABORATORY. STROKE SCALE ASSESSMENTS WILL BE CONDUCTED IN ADDITION TO THE PROPOSED INDEPENDENT NEUROLOGICAL ASSESSMENTS. THE ENDPOINT FOR THE 1500 PATIENTS ENROLLED WILL BE A 30-DAY COMPOSITE DEATH, STROKE AND MYOCARDIAL INFARCTION (MI). A PRE-OPERATIVE, DISCHARGE AND 30-DAY INDEPENDENT NEUROLOGICAL ASSESSMENT FOR ALL PATIENTS AND ASSESSMENT OF ALL DEVICE RELATED ADVERSE EVENTS WILL BE CONDUCTED....
FOLLOW FOR FIVE YEARS FROM IMPLANT PATIENTS ENROLLED IN THE PIVOTAL VSD COHORT. IN ADDITION,
A PROSPECTIVE REGISTRY STUDY OF A LEAST 100 PATIENTS WILL BE CONDUCTED TO INCLUDE EVALUATION OF ACUTE PROCEDURAL AND TECHNICAL SUCCESS, OCCURRENCE OF MAJOR COMPLICATIONS AND SHUNT CLOSURE STATUS. ANNUAL FOLLOW-UP ON A MINIMUM OF 80% OF THESE PATIENTS WILL BE OBTAINED FOR FIVE YEARS AND WILL INCLUDE A FLUOROSCOPIC EXAM IN INSTANCES WHERE ANNUAL CHEST X-RAYS ARE READ AS "UNCERTAIN: WITH REGARD TO ARM FRACTURES.
1) CORE POSTAPPROVAL STUDY. YOU MUST CONTINUE YOUR CORE STUDY UNTIL ALL PATIENTS HAVE COMPLETED
THEIR 10-YEAR EVALUATION IN ORDER TO ASSESS THE LONG-TERM CLINICAL PERFORMANCE OF YOUR PRODUCT. DATA ARE TO BE COLLECTED VIA ANNUAL PHYSICIAN FOLLOW-UP EVALUATIONS. THE PRIMARY CHANGES TO THE PROTOCOL FROM PREMARKET TO POSTAPPROVAL ARE THAT ALL NON-MRI PATIENTS WILL HAVE A MRI AT YEARS 7 AND 9 AND THAT ALL PATIENTS WHO WERE EXPLANTED WITHOUT REPLACEMENT WILL BE EVALUATED THROUGH 10 YEARS, AS PER THE PROTOCOL. YOU MUST ALSO UPDATE YOUR PATIENT AND PHYSICIAN LABELING TO REFLECT 5 AND 10-YEAR CORE STUDY FINDINGS, AS SOON AS THESE DATA ARE AVAILABLE, AS WELL AS ANY OTHER TIMEPOINT DEEMED NECESSARY BY FDA IF SIGNIFICANTLY NEW INFORMATION FROM THIS STUDY BECOMES AVAILABLE. 2) LARGE POST-APPROVAL STUDY. YOU MUST CONDUCT THE 10-YEAR LARGE POSTAPPROVAL STUDY, AS PER THE PROTOCOL THAT WAS SUBMITTED TO FDA ON OCTOBER 16, 2006. THIS STUDY, WHICH WILL BEGIN PATIENT ENROLLMENT WITHIN 90 DAYS AFTER PMA APPROVAL, WILL BE A SEPARATE STUDY FROM THE CORE STUDY AND WILL INCLUDE 39,390 ALLERGAN SILICONE GEL PATIENTS AND 19,605 SALINE-FILLED BREAST IMPLANT PATIENTS AS THE CONTROL GROUP. THE PURPOSE OF THIS STUDY IS TO ADDRESS SPECIFIC ISSUES FOR WHICH THE CORE STUDY WAS NOT DESIGNED TO FULLY ANSWER, AS WELL AS TO PROVIDE A REAL-WORLD ASSESSMENT OF SOME ENDPOINTS. THE ENDPOINTS IN THE LARGE POSTAPPROVAL STUDY INCLUDE LONG-TERM LOCAL COMPLICATIONS, CONNECTIVE TISSUE DISEASE (CTD), CTD SIGNS AND SYMPTOMS, NEUROLOGICAL DISEASE, NEUROLOGICAL SIGNS AND SYMPTOMS, OFFSPRING ISSUES, REPRODUCTIVE ISSUES, LACTATION ISSUES, CANCER, SUICIDE, MAMMOGRAPHY ISSUES, AND MRI COMPLIANCE AND RUPTURE RESULTS. (SEE APPROVAL ORDER FOR ADDITIONAL CONDITIONS...)
COLLECT DATA FOR 5 YEARS FOLOWING APPROVAL OF THE SUPPLEMENT. THE STUDY MUST COMPARE THE
RATES OF DEVICE REPLACEMENT SURGERY SUBSEQUENT TO (I) INFECTION OR (II) MECHANICAL FAILURE WITH ANTIBIOTIC IMPREGNATED AND NIMPREGNATED VERSION S OF THE DEVICE. THIS COMPARISON MUST BE PERFORMED ON AN ANNUAL BASIS USING APPROPRIATE STATISTICAL TECHNIQUES, AND MUST STRATIFY PATIENTS BY THE FOLLOWING CRITERIA: POST-OPERATIVE TIME TO INFECTION WITH PRIOR IMPLANT (I.E.<2 MONTH VERSUS 1-12 MONTHS) AND PRIOR REVISION SURGERY. THE DATA USED FOR THIS COMPARISON WILL BE OBTAINED FROM THE PATIENT INFORMATION FORM (PIF) DATABASE, WHICH TRACKS ALL IMPLANTED AMS SPHINCTER 800 URINARY CONTROL SYSTEMS.
POST APPROVAL STUDY PROTOCOL FOR EXAMINING THE SAFETY OF COSMETIC TISSUE AUGMENTATION PRODUCT (CTA) IN
PERSONS O COLOR. THE PROTOCOL SHOULD DESCRIBE AN OPEN-LABEL, LONGITUDINAL, UNCONTROLLED, STUDY IN A MINIMUM OF 100 PATIENTS WITH FITZPATRICK SKIN TYPES 4,5 OR 6 AT 10 OR MORE U.S. CENTERS WHO HAVE ELECTED TO UNDERGO NASOLABIAL FOLD TREATMENT WITH INTRADERMAL (DEEP DERMAL) INJECTION OF CTA. PATIENTS WILL BE FOLLOWED FOR A MINIMUM OF 24 WEEKS WITH VISITS ASSESSMENT OF PAIN, TENDERNESS, REDNESS, ECCHYMOSIS, SWELLING, ITCHING, MASS (NODULE / CYST / ABSCESS) FORMATION, DERMAL PIGMENTATION AND KELOID CHANGES AT THE SITE OF INJECTION AT EACH FOLLOW-UP POINT POST-OPTIMAL COSMESIS. THE PURPOSE OF THE STUDY IS TO GAIN ADDITIONAL SAFETY INFORMATION, INCLUDING THE LIKELIHOOD OF KELOID FORMATION, IN PATIENTS WITH FITZPATRICK SCALE SKIN TYPES 4, 5 AND 6. SAFETY ENDPOINT ASSESSMENTS OF THIS STUDY ARE: 1) KELOID FORMATION AT THE SITE OF INJECTION AT 12 AND 24 WEEKS; 2) PIGMENTATION CHANGES AT THE SITE OF INJECTION COMPARED TO ADJACENT SKIN AT 2 AND 6 WEEKS; 3) ADVERSE EXPERIENCE ASSESSMENT; AND 4) A PATIENT DIARY SYMPTOM PROFILE. THE RESULTS TO BE SUBMITTED TO FDA ON AN ANNUAL BASIS IN POST APPROVAL STUDY REPORTS.
EXAMINE THE SIGNIFICANCE OF DELAYED GRANULOMA FORMATION IN ARTEFILL IMPLANT-TREATED PATIENTS. THE STUDY WILL ENROLL
1,000 PATIENTS AND MONITOR THESE PATIENTS FOR GRANULOMA FORMATION FOR 5 YEARS AFTER THE DATE OF THEIR FIRST TREATMENT WITH A LOST TO FOLLOW-UP THAT DOES NOT EXCEED 20% OF THE PATIENTS ENROLLED IN THE STUDY. STUDY ENROLLMENT WILL BEGIN WITHIN 6 MONTHS OF THE APPROVAL DATE; THE LAST PATIENT WILL BE ENROLLED WITHIN 18 MONTHS OF THE APPROVAL DATE; AND A FINAL REPORT WILL BE SUBMITTED 5.5 YEARS AFTER THE LAST PATIENT IS ENROLLED.
5 YR POSTAPPROVAL STUDY ON MINIMUM OF 200 SUBJECTS TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS
OF DEVICE (E.G., DURABILITY OF THE TREATMENT EFFECT, RE-INJECTION RATE, THE IMPACT OF RE-TREATMENTS) AND TO ASSESS THE INCIDENCE OF TISSUE EROSION AND OTHER ADVERSE EVENTS. THE TOTAL ENROLLMENT OF SUBJECTS MAY BE 500-1000 SUBJECTS BASED UPON THE ESTIMATED LOST OF FOLLOW-UP.
PROVIDE THE RESULTS OF AN OPEN-LABEL, POSTAPPROVAL STUDY IN 100 PATIENTS WITH FITZPATRICK SKIN TYPES
4,5 OR 6 FROM FIVE OR MORE U.S. CENTERS WHO HAVE ELECTED TO UNDERGO NASO-LABIAL FOLD TREATMENT WITH SUBDERAL INJECTION OF RADIESSE. PATIENTS WILL BE FOLLOWED FOR A MINIMUM OF 24 WEEKS WITH VISITS FOR ASSESSMENT OF DERMAL PIGMENTATION AND KELOID CHANGES AT THE SITE OF INJECTION AT EACH FOLLOW-UP POINT POST-OPTIMAL COSMESIS. THE PURPOSE OF THE STUDY IS TO ASSESS THE LIKELIHOOD OF HYPERTROPHIC SCARRING AND KELOID FORMATION, IN PATIENTS WITH FITZPATRICK SCALE SKIN TYPES 4, 5 AND 6. SAFETY ENDPOINT ASSESSMENTS OF THIS STUDY ARE: 1) HYPERTROPHIC SCARRING OR KELOID FORMATION AT THE SITE OF INJECTION AT 12 AND 24 WEEKS; 2) PIGMENTATION CHANGES AT THE SITE OF INJECTION COMPARED TO ADJACENT SKIN AND; 3) ADVERSE EXPERIENCE ASSESSMENT. STUDY ENROLLMENT WILL BEGIN WITHIN 18 MONTHS OF THE APROVAL DATE; AND A FINAL REPORT WILL BE SUBMITTED WITHIN 2.5 YEARS OF THE APPROVAL DATE. ADDITIONALLY, POSTAPPROVAL REPORTS FOR THIS STUDY WILL BE SUBMITTED ANNUALLY INDEPENDENTLY OF OTHER REPORTS. PROVIDE THE RESULTS OF AN OPEN LABEL POSTAPPROVAL STUTDY IN 100 PATIENTS TO COLLECT LONG-TERM SAFETY INFORMATION ON THE USE OF RADIESSE INJECTED INTO NASOLABIAL FOLDS AND THE EFFECT OF MULTIPLE INJECTIONS. THE STUDY WILL ENROLL 100 PATIENTS AND MONITOR THESE PATIENTS FOR 3 YEARS AFTER THE DATE OF THEIR FIRST TREATMENT WITH A LOST TO FOLLOW-UP THAT DOES NOT EXCEED 20% OF THE PATIENTS ENROLLED. A FINAL REPORT WILL BE SUBMITTED WITHIN 4 YEARS AFTER THE APPROVAL DATE. IN ADDITION, POST APPROVAL REPORTS FOR THIE STUDY WILL BE SUBMITTED ANNUALLY INDEPENDENTLHY OF OTHER REPORTS.
PERFORM A 10 YR POST MARKETING PROSPECTIVE HIP STUDY ENROLLING A MINIMUM OF 257 PRIMARY
TOTAL HIP REPLACEMENTS OF WHOM A MINIMUM OF 160 PATIENTS WILL BE FOLLOWED OUT TO FIVE (5) YEARS AND A MINIMUM OF 100 PATIENTS WILL BE FOLLOWED OUT TO 10 YRS. BILATERAL PATIENTS HAVING EITHER SIMULTANEOUS OR STAGED REPLACEMENTS ARE COUNTED AS TWO REPLACEMENTS. IN THE EVENT THAT ONE OR MORE IMPLANTS (I.E. LINER, HEAD, SHELL AND/OR STEM) ARE REMOVED/REVISED FROM THE HIP REPLACEMENT, THAT SIDE WILL NO LONGER BE FOLLOWED AND WILL BE INCLUDED IN THE SAFETY DATA. THE STUDY WILL INVOLVE TWO (2) PHASES IN A DEFINED PATIENT POPULATION. THE FIRST PHASE OF THE INVESTIGATION GATHERS CLINICAL, RADIOGRAPHIC, AND SURVIVORSHIP DATA FOR FIVE YEARS FOLLOWING IMPLANTATION. IF DURING THE INITIAL FIVE (5) YEARS A PATIENT MISSES A FOLLOR-UP, A SELF-ASSESSMENT FORM WILL BE SENT TO THE PATIENT. THE SECOND PHASE IMMEDIATELY FOOLWS THE FIRST STARTING AT YEAR SIX (6) AND COUNTINUES UNTIL YEAR TEN (10) THIS PHASE UTILIZES MAILINGS TO GATHER SURVIVORSHIP INFORMATION. RESPORT EACH ADVERSE EVENT INCLUDING DETAILS OF NATURE, ONSET, DURATION, SEVERITY, RELATIONSHIP TO DEVICE, AND RELATIONSHIP TO THE OPERATIVE PROCEEDURE AND OUTCOME. INITIATE THE STUDY WITHIN 6 MONTHS OF APPROVAL OF PMA.
1) PROTOCOL DETAILING THE ADDITINOAL CHARACTERIZATION TESTING THAT WILL BE PERFORMED ON THE CURRENT LOT
OF WORKING REFERENCE STANDARD. 2) THE QUALIFICATION PROTOCOL FOR A NEW WORKING REFERENCE STANDARD FOR THE APPROVAL. THIS SHOULD BE DONE PRIOR TO INITIATING THE STUDY SO THAT THE PROTOCOL CAN BE REVIEWED AND ANY NECESSARY FEEDBACK CAN BE PROVIDED. 3) IN THE FUTURE, AS PART OF QUALIFYING A NEW WORKING REFERENCE STANDARD, PLEASE PROVIDDE NOVARTIS` CERTIFICATE OF ANALYSIS ASSOCIATED WITH THE LOT OF MATERIAL THAT WILL BE USED AS THE NEW WORKING REFERENCE STANDARD.
IN ACCORDANCE WITH THE STUDY PROTOCOL SUBMITTED AUGUST 4, 2006, YOU WILL ENROLL 249 SUBJECTS
IN A CONDITION OF APPROVAL STUDY. THE PURPOSE OF THIS STUDY IS (1) TO CONFIRM THE POINT ESTIMATES OF SAFETY AND EFFECTIVENESS AT ADDITIONAL CENTERS TO MORE COMPLETELY CHARACTERIZE THE GENERALIZABILY OF THE PREMARKET CLINICAL DATA TO THE BROADENED CLINICAL POPULATION; (2) TO PROSPECTIVELY MEASURE 12-MONTH MORTALITY AND DETERMINE WHETHER A PATIENT POPULATION WITH A LOW LEFT VENTRICULAR EJECTION FRACTION (LVEF < 30%) IS AT GREATER RISK OF DEATH; AND (3) TO DETERMINE THE LONG-TERM (3 YEARS) EFFECT OF VT ABLATION ON CARDIAC FUNCTION. YOU HAVE AGREED TO PROVIDE QUARTERLY REPORTS OF THE STUDY PROGRESS IN ADDITION TO THE ANNUAL REPORTS SPECIFIED IN THE CONDITIONS OF APPROVAL.
COLLECT LONG TERM SURVIVAL DATA ON APPROXIMATELY 100 PATIENTS PREVIOUSLY ENROLLED IN THE CLINICAL INVESTIGATION
OF THE TUPOS CRT-D. THE PATIENTS WILL BE FOLLOWED EVERY 6 MONTHS FOR A PERIOD OF 3 YEARS. THE POSTAPPROVAL STUDY WILL REPORT LV CAPTURE THRESHOLD AND SPECIFIC LV RELATED COMPLICATION S SUCH AS DIAPHRAGMATIC STIMULATION AND LOSS OF LEFT VENTRICULAR CAPTURE. ALSO, CONFIRM THE LONG TERM SAFETY AND EFFECTIVENESS OF THE COROX LEAD USED IN CONJUNCTION WITH A BIOTRONIK CRT-D IN AT LEASE 250 PATIENTS FOLLOWED FOR 3 YEARS. THE POSTAPPROVAL STUDY WILL PROVIDE DATA TO PERMIT A CHARACTERIZATION OF ANY LV LEAD FAILURES CONTRIBUTING TO PATIENTS LOSING CRT THERAPY.
ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL DELIVERY SYSTEM
Cardiovascular
10/27/2006
1) COMPLETE THE 3-YEAR FOLLOW-UP STUDY OF THE REGISTRY PATIENTS UNDER CABERNET. THE GOALS OF
THIS FOLLOW-UP STUDY ARE TO EVALUATE THE LONGER-TERM SAFETY AND EFFECTIVENESS OF THE ENDOTEX NEXSTENT CAROTID ARTERY SYSTEM (OTW AND MR) WITH EMBOLIC PROTECTION. AT EACH ANNUAL VISIT, A CLINICAL EXAMINATION, A CAROTID DUPLEX ULTRASOUND, AND A NEUROLOGICAL EXAM (NIHSS) WILL BE CONDUCTED. CLINICAL DATA WILL BE RECORDED ON THE CORRESPONDING CASE REPORT FORMS (CRFS). DIAGNOSTIC STUDIES ON PATIENTS IN THIS COHORT WILL CONTINUE TO BE EVALUATED BY THE CORE LABORATORY. ALL DATA WILL BE MONITORED, ENTERED INTO A DATABASE, ANALYZED AND SUBMITTED IN ANNUAL REPORTS TO THE FDA AND A FINAL REPORT WILL BE SUBMITTED AFTER COMPLETION OF THE FOLLOW-UP AND ANALYSIS. THIS FOLLOW-UP PROPOSAL WILL ALLOW AN EVALUATION OF ADVERSE EVENTS, NEUROLOGICAL EVENTS, AND PERCENT STENOSIS. 2) YOU HAVE AGREED TO PERFORM A POST-APPROVAL STUDY ENTITLED SONOMA. THE MOST RECENT VERSION WAS AGREED UPON OCTOBER 12, 2006 AND IS SUBTITLED ¿REVISION 6¿ RECEIVED BY ELECTRONIC MAIL ON OCTOBER 12, 2006. THE GOALS OF THIS STUDY ARE TO CONFIRM THE SAFETY OF THE NEXSTENT CAROTID STENT SYSTEM (OTW OR MR) IN ROUTINE CLINICAL PRACTICE AND TO IDENTIFY RARE OR UNANTICIPATED DEVICE-RELATED EVENTS THAT MIGHT OCCUR WITH THE USE OF THIS DEVICE. YOU AGREE TO FOLLOW ALL 1500 PATIENTS AT TIMEPOINTS OF 30-DAYS AND 12-MONTHS OF IMPLANTATION AND TO FOLLOW AND ASSESS A COHORT OF 500 PATIENTS THROUGH ONE YEAR OF IMPLANTATION BY INDEPENDENT CORE LAB ANALYSIS OF THEIR DUPLEX ULTRASOUND EVALUATIONS. (SEE APPROVAL ORDER FOR ADD`L INFO)
LIBERTE MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS
Cardiovascular
04/12/2005
EVALUATE THE LONGER-TERM OUTCOMES ASSOCIATED WITH THE LIBERTE STENT, YOU SHOULD COLLECT AND REPORT TO
THE AGENCY CLINICAL OUTCOMES THROUGH 6 MONTHS POST-PROCEDURE ON AT LEAST 80% OF THE PATIENTS ENROLLED IN THE ELECT STUDY. WHEN APPROPRIATE OR AS REQUESTED BY FDA, YOU SHOULD SUBMIT A PMA SUPPLEMENT REQUESTING APPROVAL TO UPDATE YOUR IFU TO INCLUDE THESE DATA.
1) CONDUCT A POST-APPROVAL STUDY IN AT LEAST 270 PATIENTS WITH STENOTIC LESIONS AT THE
VENOUS ANASTOMOSIS OF A SYNTHETIC AV ACCESS GRAFT AT UP TO 20 CLINICAL SITES. THE PURPOSE OF THIS STUDY IS TO ASSESS THE LONG-TERM PERFORMANCE OF THE FLAIR ENDOVASCULAR STENT GRAFT AND THE ACUTE PERFORMANCE OF THE OPTIMIZED DELIVERY SYSTEM. THE POST-APPROVAL STUDY WILL BE A PROSPECTIVE, RANDOMIZED, CONCURRENTLY-CONTROLLED STUDY ENROLLING PATIENTS TO BE TREATED WITH THE FLAIR ENDOVASCULAR STENT GRAFT AND PTA OR PTA ALONE. THREE PRIMARY OBJECTIVES WILL BE EVALUATED FOR THIS STUDY AS FOLLOWS: 1) SUPERIORITY OF THE FLAIR DEVICE TO PTA WITH RESPECT TO PRIMARY PATENCY; 2) NON-INFERIORITY OF THE FLAIR DEVICE TO PTA WITH RESPECT TO THE INDEX OF PATENCY FUNCTION, DEFINED AS THE TIME FROM THE INDEX STUDY PROCEDURE TO COMPLETE GRAFT ABANDONMENT DIVIDED BY THE NUMBER OF VISITS FOR AN INTERVENTION PERFORMED ON THE AV ACCESS CIRCUIT IN ORDER TO MAINTAIN VASCULAR ACCESS FOR HEMODIALYSIS; AND 3) NON-INFERIORITY OF THE FLAIR DEVICE TO PTA WITH RESPECT TO SAFETY. ASSISTED PRIMARY PATENCY, SECONDARY PATENCY, PROCEDURAL SUCCESS, NUMBER OF REINTERVENTIONS UNTIL GRAFT ABANDONMENT, AND NUMBER OF DEVICE/PROCEDURE RELATED ADVERSE EVENTS WILL ALSO BE EVALUATED. PATIENTS WILL BE FOLLOWED FOR 24 MONTHS POST-PROCEDURE. IN ADDITION, AS PART OF YOUR POST-APPROVAL STUDY, THE EFFECTIVENESS OF YOUR TRAINING PROGRAM WILL BE ASSESSED BY THE INCIDENCE OF MAJOR DEVICE-RELATED EVENTS THROUGH 30 DAYS. 2) PROVIDE A CLINICAL UPDATE OF YOUR ONGOING EXPERIENCE WITH THE FLAIR ENDOVASCULAR STENT GRAFT TO PHYSICIAN USERS AT LEAST ANNUALLY THROUGH FIVE YEARS POST-APPROVAL. AT A MINIMUM, THIS UPDATE WILL INCLUDE A SUMMARY OF THE NUMBER OF PATIENTS FOR WHOM DATA ARE AVAILABLE, WITH THE RATES OF PRIMARY PATENCY, PRIMARY ASSISTED PATENCY, AND SECONDARY PATENCY, AS WELL AS THE NUMBER OF REINTERVENTIONS AND DEVICE/PROCEDURE RELATED ADVERSE EVENTS....
