The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Multi-Center, Prospective, Post-Market, Confirmatory, Interventional, Investigation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 6
- 主要终点
- Safety: Device and Procedure Related Serious Adverse Events (SAEs) - Presented as the Number of Participants With Freedom From Clinical Events Committee (CEC) Adjudicated Device and/or Procedure-Related SAEs.
研究概览
简要总结
This is a global, multi-center, prospective, post-market, confirmatory, interventional, non-randomized, single-arm clinical investigation evaluating arteriovenous fistula (AVF) creation by means of the WavelinQ™ EndoAVF System in patients who require a vascular access for hemodialysis (HD).
详细描述
The purpose of this clinical investigation is to provide clinical evidence to further demonstrate reasonable assurance of safety and effectiveness of the WavelinQ™ EndoAVF System when used for endovascular arteriovenous fistula (endoAVF) creations. Treated participants will be followed for 24-months post index procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant must:
- •Be able to comprehend, voluntarily sign and date the informed consent form (ICF) prior to collection of clinical investigation data or performance of clinical investigation procedures (or where allowable the participant's legally authorized representative (LAR) on behalf of the participant).
- •Be able to and willing to comply with the CIP requirements, including clinical follow-up.
- •Be male or non-pregnant female ≥ 18 years of age with an expected lifespan sufficient (≥ 24 months) to allow for completion of all clinical investigation procedures.
- •Have established, non-reversible kidney failure, who are currently on HD at screening or are in need of a vascular access for HD as determined by the referring clinician.
- •Target treatment vein diameter(s) for AVF creation ≥ 2.0 mm as measured via DUS or angiography.
- •A target treatment artery diameter ≥ 2.0 mm as measured via DUS or angiography.
- •Adequate collateral circulation to the hand, in the opinion of the Principal Investigator (PI) (or authorized designee).
- •At least one superficial outflow vein diameter ≥ 2.5 mm as measured via DUS or angiography that is in communication with the target creation site via a proximal forearm perforating vein.
排除标准
- •The participant must not have:
- •Active or nontreated hypercoagulable state.
- •Known bleeding diathesis.
- •Insufficient cardiac output to support the maturation and use of an AVF in the opinion of the PI (or authorized designee).
- •Known history of or current active intravenous drug abuse.
- •A "planned" major surgical procedure within 6 months following index procedure or major surgery, in the opinion of the PI (or authorized designee), within 30 days prior to index procedure.
- •Known allergy or hypersensitivity to contrast media which cannot be adequately treated with pre-medication.
- •Known adverse effects to sedation and / or anesthesia which cannot be adequately treated with pre-medication.
- •Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and / or White Blood Cell (WBC) Count of ≥ 12,000 cells / μL, if collected).
- •Another medical condition, which, in the opinion of the PI (or authorized designee), may cause him / her to be non-compliant with the CIP, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of clinical investigation procedures and follow-up.
- •Current participation in an investigational drug or device clinical investigation that has not completed the clinical investigation treatment or that clinically interferes with the clinical investigation endpoints. Note: Investigations requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational.
- •Central venous stenosis or central vein narrowing ≥ 50% based on imaging, or any degree of central venous stenosis with accompanying signs or symptoms, on the same side as the planned AVF creation.
- •The absence of a proximal forearm perforating vein feeding the target cannulation vein(s) from the target creation site via DUS or angiography.
- •Occlusion or stenosis ≥ 50%, or any degree of stenosis with accompanying signs or symptoms of target cannulation vein(s) such as cephalic, median cubital, basilic, etc. assessed via DUS or angiography and as clinically determined by PI (or authorized designee).
- •Significantly compromised venous or arterial architecture (e.g. severe vessel calcification) or flow in the treatment arm as determined by the PI (or authorized designee) and DUS or angiography.
- •Presence of significant calcification at the target endoAVF location that could potentially impact the effectiveness of endoAVF creation as determined by the PI (or authorized designee).
结局指标
主要结局
Safety: Device and Procedure Related Serious Adverse Events (SAEs) - Presented as the Number of Participants With Freedom From Clinical Events Committee (CEC) Adjudicated Device and/or Procedure-Related SAEs.
时间窗: 30 days
Clinical Investigation Plan (CIP) Endpoint Definition: The proportion of participants with freedom from CEC adjudicated device- or procedure-related SAEs. The CEC established criteria to determine the relatability of an adverse event (AE) to the device and/or the index procedure. Based on these criteria, AEs were adjudicated to be "definitely related", "possibly related", or "not related". Events adjudicated to be "definitely" or "possibly" related were considered to be related events. NOTE: Due to early termination of the investigation, this endpoint is presented as the number of participants with freedom from CEC adjudicated device- or procedure-related SAEs.
Effectiveness: Number of Interventions Per Patient Years to Facilitate and / or Maintain AVF Use
时间窗: 6 months
CIP Endpoint Definition: The number of interventions per patient years to facilitate and / or maintain AVF use (facilitation interventions and / or maintenance interventions). The assessment of interventions to facilitate and/or maintain AVF use started post creation (after the completion of the index procedure). NOTE: For the calculation of the endpoint, the number of Interventions per Patient Years to Facilitate and / or Maintain AVF Use was to be estimated by using the Poisson regression model. Given the early termination of the investigation the mean and standard deviation of the Number of Interventions and Patient Years used for the derivation are provided in the Analysis Population Description.
次要结局
- Device and Procedure Related SAEs - Presented as the Number of Participants With Freedom From CEC Adjudicated Device and/or Procedure-Related SAEs.(6 months (24 months was also to be reported per the CIP but due to investigation early termination only data through 6 months was able to be evaluated).)
- Physiological Maturation - Presented as the Number of Participants With AVFs That Meet the CIP Definition of Physiological Maturation as Measured by Duplex Ultrasound (DUS).(6 weeks)
- Cannulation Success - Presented as the Percentage of Participants With Cannulation Success.(6 months)
- Cannulation Success - Presented as the Number of Days to Cannulation Success.(Through Investigation Early Termination)
- Cumulative Functional Patency - Presented as the Number of Participants With Cumulative Functional Patency(6 months (12 months per CIP but due to investigation early termination data is reported through 6 months instead due to the limited resultant data available at 12 months))