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治験 NCT03242343（対象：動静脈瘻、末期腎疾患（ESRD）、Steal Syndrome、動脈瘤、腎不全、腎疾患、糖尿病、腎不全）は完了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
VasQ External Support for Arteriovenous Fistula 144
All patients will be implanted with the VasQ device and will be followed up for a duration of 24 months.
A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula
- CD0121
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的VasQ device implantation Main study cohort: Prospective, multi-center, single-arm, open label, enrolling patients referred to surgical creation of new brachiocephalic fistula (BCF). The VasQ will be applied to the AV fistula in all patients. The primary effectiveness endpoint for this trial will be measured at 6 months and compared to a performance goal (PG). Safety will compare descriptively between AE rates for Steal, Infection, Aneurysm a...もっと見る | VasQ An external support device for AV fistula |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Primary Patency of AVF | Proportion of patients with freedom from intervention since device placement | 6 months post AVF creation |
Occurrence of safety events | The occurrence per patient access related safety events | Device implantation to 6 months post AVF creation |
Main study cohort: Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study and which are not indicated for a more distal fistula per treatment guidelines.
Supplementary study cohort: Patients referred for creation of a new forearm fistula who consent to take part in the study.
Male and female participants.
Age 18-80 years.
Patients willing and able to attend follow up visits over a period of 24 months.
Patients with the planned index procedure being a revision surgery of an existing fistula.
Main study cohort: Target artery smaller than 2.5 mm or larger than 6 mm in inner diameter by preoperative ultrasound.
Supplementary study cohort: Target artery smaller than 2 mm or larger than 4.1 mm in inner diameter by preoperative ultrasound.
Main study cohort: Target vein smaller than 2.5 mm in inner diameter by preoperative ultrasound.
Supplementary study cohort: Target vein smaller than 2 mm in inner diameter by preoperative ultrasound.
Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the area between the planned anastomosis site and the Axillary vein.)
Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
Patients with central venous stenosis or obstruction on the side of surgery.
Depth of vein greater than 8 mm (on ultrasound) on side of surgery.
Known coagulation disorder.
Congestive heart failure NYHA class ≥ 3.
Prior steal on the side of surgery.
Known allergy to nitinol.
Life expectancy less than 30 months.
Patients expecting to undergo kidney transplant within 6 months of enrollment.
Women of child bearing age without documented current negative pregnancy test.
Inability to give consent and/or comply with the study follow up schedule.
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