NCT04671771Toboroz
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 8.
Rövid összefoglaló (regiszter, angolul)
The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are: Primary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months. Primary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months. Participants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 133 (tervezett)
- Első benyújtás
- 2020. dec. 5.
- Kezdés
- 2020. dec. 3.
- Elsődleges befejezés
- 2030. márc. 1.
- Fő szponzor
- W.L.Gore & Associates
- Betegségek
- Krónikus vesebetegség
- NCT-szám
- NCT04671771
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 133
- 2020. dec. 3. és az elsődleges befejezés (2030. márc. 1.) között
- 22 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Kiket keres a vizsgálat
- Pre-Operative Inclusion Criteria:
- Patients must meet the following criteria at screening in order to be scheduled for a procedure and potentially enrolled in the study:
- Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy;
- Age 18 to 90 years old, inclusive;
- Suitable anatomy for implantation of upper arm "straight" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow);
- Ability to continue or commence antiplatelet therapy post graft implant (anticoagulation medication is acceptable if the subject is required to take an anticoagulant for a baseline medical condition);
- Able and willing to give informed consent;
- Anticipated life expectancy of at least 1 year.
- Intra-Operative Inclusion Criteria:
- Both vessels have been exposed and are deemed appropriate for implantation (i.e., based on the surgeon's opinion, artery is of adequate size, has adequate pulse to support AV access flow, is without significant calcification, and is safely clampable; and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction).
- Pre-Operative Exclusion Criteria:
- Patients will be excluded from the study at screening if they exhibit any of the following exclusion criteria:
- History or evidence of severe cardiac disease (i.e., debilitating heart failure, or high risk of MI) in the opinion of the investigator which may preclude participation in and completion of the study;
- Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations);
- For upper arm straight configuration, an antecubital fossa crease to axillary crease distance < 18 cm;
- History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e., arterial inflow insufficient to support hemodialysis access);
- Known or suspected central vein stenosis or obstruction on the side of planned graft implantation;
- Baseline hypotension or history of frequent hypotensive episodes during dialysis that, in the opinion of the investigator, puts the patient at increased risk of graft thrombosis;
- Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness);
- Baseline hemoglobin <7 g/dL;
- Baseline platelet count <50,000 or >500,000 cells/mm3;
- Documented history of stroke within 6 months prior to enrollment;
- Treatment with any investigational drug or device within 30 days prior to enrollment;
- Female patients who are pregnant, intending to become pregnant, nursing or intending to breastfeed during the study (pregnancy test may only be omitted, if patient is post-menopausal or has a documented history of hysterectomy or permanent sterilization);
- History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin;
- Immunodeficiency including documented history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) or patients receiving immunosuppressive therapy for treatment of an acute inflammatory event or autoimmune flare. Chronic immunosuppressive therapy is acceptable;
- Documented or suspected hypercoagulable condition;
- Bleeding diathesis, other than that associated with ESRD;
- Documented history of heparin-induced thrombocytopenia (HIT);
- Active local or systemic infection as documented from the medical history or bloodwork/blood culture data. If the infection resolves, the subject must be at least one-week post resolution of that infection before implantation;
- Scheduled renal transplant within 6 months;
- Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and effectiveness of the IG;
- Patient is unable or unwilling to complete all required follow-up assessments and questionnaires.
Életkor a regiszterben: 18 év – 90 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (22)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Piedmont Augusta | Augusta | Egyesült Államok | Toboroz |
| University of Maryland | Baltimore | Egyesült Államok | Toboroz |
| Brigham & Women's Hospital | Boston | Egyesült Államok | Toboroz |
| Surgical Specialists of Charlotte | Charlotte | Egyesült Államok | Toboroz |
| Duke University Medical Center | Durham | Egyesült Államok | Toboroz |
| Prisma Health-Upstate | Greenville | Egyesült Államok | Toboroz |
| Houston Methodist Hopsital | Houston | Egyesült Államok | Toboroz |
| Sharp Center for Research | La Mesa | Egyesült Államok | Toboroz |
| University of Louisville | Louisville | Egyesült Államok | Toboroz |
| Rutgers | Newark | Egyesült Államok | Toboroz |
| Mount Sinai Hospital | New York | Egyesült Államok | Toboroz |
| Northwell Health | New York | Egyesült Államok | Toboroz |
| Methodist Physicians Clinic | Omaha | Egyesült Államok | Toboroz |
| Medical University of South Carolina | Orangeburg | Egyesült Államok | Toboroz |
| AKDHC Medical Research Services, LLC | Phoenix | Egyesült Államok | Toboroz |
| NC Heart and Vascular Research, LLC | Raleigh | Egyesült Államok | Fut, nem toboroz |
| Wakemed | Raleigh | Egyesült Államok | Toboroz |
| Sarasota Memorial Hospital | Sarasota | Egyesült Államok | Toboroz |
| Guthrie Clinic | Sayre | Egyesült Államok | Toboroz |
| University of Washington | Seattle | Egyesült Államok | Toboroz |
| University of South Florida | Tampa | Egyesült Államok | Toboroz |
| Montefiore Medical Center | The Bronx | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.