The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry ("The CALIBER Registry")
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Composite of Major Adverse Events (MAE)
研究概览
简要总结
The goal of this observational study is to gather additional safety and performance (effectiveness) data on the device for the treatment of symptomatic lower extremity venous obstructions and occlusions. The main questions the study aims to answer are:
- What is the observed rate of safety events through the 30-day follow-up?
- What is the rate of technical success (acute procedural success) achieved at the index procedure?
Participants already undergoing treatment with the Recana as part of their regular medical care will be followed for 1 year.
详细描述
The CALIBER Registry is a prospective, multi-center, non-randomized, non-interventional (observational) registry of the Recana Thrombectomy Catheter System for the treatment of symptomatic venous obstruction and occlusions. Commensurate with the continuum of care and usual practice for the follow-up of the study population, subjects are assessed at post-procedure/discharge, 30-day (30D), 180-day (180D) and 365-day (365D) post-index procedure [reporting on these timepoints are based on standard of care clinic visits that occur closest to timepoints at 30D, 180D and 365D post-procedure].
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •INCLUSION CRITERA:
- •A. Native Vessel:
- •INC-1: Subject is 18 years or older
- •INC-2: Proximal lower extremity obstruction/occlusion involving the femoral, common femoral, iliac veins, or inferior vena cava (IVC), alone or in combination that in the opinion of the investigator, treatment with the Recana would benefit the patient
- •INC-3: Recana Thrombectomy Catheter System must enter vasculature
- •INC-4: Willing and able to provide written informed consent
- •B. In-Stent Restenosis:
- •INC-1: Subject is 18 years or older
- •INC-2: Subjects with stents implanted greater than 6 weeks prior to index procedure
- •INC-3: Location of thrombosed stents in proximal lower extremity deep vein segments including common femoral, external iliac, common iliac vein, or inferior vena cava alone or in combination that in the opinion of the investigator treatment with the Recana would benefit the patient
- •INC-4: Recana Thrombectomy Catheter System must enter vasculature
- •INC-5: Willing and able to provide written informed consent
- •EXCLUSION CRITERA
- •A. Native Vessel:
- •EXC-1: IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins
- •EXC-2: IVC filter in place at the time of index procedure that, in the judgment of the investigator, may interfere with the procedure
- •EXC-3: Congenital anatomic anomalies of the iliac veins that in the opinion of the investigator would preclude treatment with the Recana
- •EXC-4: Heparin allergy or hypersensitivity that cannot be adequately managed with alternate anticoagulant during or after the procedure, or prior diagnosis of HIT (Heparin-Induced Thrombocytopenia)
- •EXC-5: Severe, life-threatening allergy to iodine or contrast dye
- •EXC-6: Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period
- •EXC-7: Life expectancy less than 1 year
- •EXC-8: Chronic non-ambulatory status such as long-term wheelchair requirement or bedridden status
- •EXC-9: Known hypercoagulable states that, in the opinion of the investigator, cannot be medically managed throughout the study period
- •EXC-10: Inability to secure venous access and cross lesion
- •EXC-11: Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
- •EXC-12: Current active participation in another investigational drug or device study in which the primary endpoint has not been analyzed
- •B. In-Stent Restenosis:
- •EXC-1: Exposed stents with broken struts, significantly deformed struts, struts protruding into the vessel
- •EXC-2: Stent failure caused by undersizing or malapposition of the stent(s) [For example, the segment of a stent in the iliac vein that is not wall apposed or cannot be apposed to the wall after balloon dilation is excluded. The segment of a stent that extends into the IVC that is not wall apposed would not be excluded.]
- •EXC-3: Stents compressed to <6mm that remain <6mm after balloon dilation
- •EXC-4: IVC filter in place at the time of index procedure that, in the judgment of the investigator, may interfere with the procedure
- •EXC-5: Congenital anatomic anomalies of the iliac veins that in the opinion of the investigator would preclude treatment with the Recana
- •EXC-6: Heparin allergy or hypersensitivity that cannot be adequately managed with alternate anticoagulant during or after the procedure, or prior diagnosis of HIT (Heparin-Induced Thrombocytopenia)
- •EXC-7: Severe, life-threatening allergy to iodine or contrast dye
- •EXC-8: Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period
- •EXC-9: Life expectancy less than 1 year
- •EXC-10: Chronic non-ambulatory status such as long-term wheelchair requirement or bedridden status
- •EXC-11: Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period
- •EXC-12: Inability to secure venous access and cross lesion
- •EXC-13: Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
- •EXC-14: Current active participation in another investigational drug or device study in which the primary endpoint has not been analyzed
排除标准
- 未提供
研究组 & 干预措施
Intention to Treat (ITT) Population
The Intention-to-Treat (ITT) population is defined as all consented subjects who are determined to be candidates for treatment with the Recana Thrombectomy Catheter System, independent of the procedure being initiated or completed.
Primary Analysis Set (PAS) Population
The Primary Analysis Set (PAS) population is a subset of the Full Analysis Set (FAS) population with unilateral or bilateral venous obstructions or occlusions without recent (≤3 months) venous intervention. The first 87 subjects in the FAS population who meet these criteria will complete the Primary Analysis Set population.
干预措施: Recanalization and debulking (Device)
Full Analysis Set (FAS) Population
The Full Analysis Set (FAS) population is defined as all consented subjects who are determined to be are appropriate candidates for treatment with the Recana Thrombectomy Catheter System and undergo the study procedure. The study will consist of up to 500 subjects in the FAS population.
干预措施: Recanalization and debulking (Device)
结局指标
主要结局
Composite of Major Adverse Events (MAE)
时间窗: From Index Procedure (Day 0) to 30-Days Post-Procedure
Composite of Major Adverse Events (MAE) where MAE is a combined clinical endpoint of death (all-cause mortality), major bleeding, and symptomatic pulmonary embolism
Technical Success (Acute Procedural Success)
时间窗: Index Procedure (Day 0)
* In-stent restenosis (ISR) venous segment: defined as patency ≥50% luminal diameter utilizing IVUS * Native venous segment: defined as patency ≥50% luminal diameter utilizing IVUS
次要结局
- Incidence rates of the following: (1) Individual components of the MAE composite endpoint; (2) Minor bleeding; and (3) Access site complications from the index procedure (hematoma, false aneurysm, perforation)(From Index Procedure (Day 0) to 30-Days Post-Procedure)
- Incidence rate of device-related death(From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure)
- Incidence rate of procedure-related death(From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure)
- Patency rates of Target Venous Segment (TVS)(From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure)
- Incidence rate of device-related rethrombosis of the Target Venous Segment (TVS)(From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure)
- Incidence rate of deep venous thrombosis (DVT) outside of the Target Venous Segment (TVS)(From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure)
- Comparison of baseline target limb edema to the 365-Days Post-Procedure score(From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure)
- Comparison of baseline revised Venous Clinical Severity Score (rVCSS) to the rVCSS at 365-Days Post-Procedure(From Index Procedure (Day 0) through study completion up assessed to 365-days post-procedure)
- Comparison of baseline VEINES Quality of Life (QoL)/Symptom (Sym) Scores with the VEINES Quality of Life (QoL)/Symptom (Sym) Scores obtained 365-Days Post-Procedure(From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure)
- Comparison of baseline Villalta Score with the Villalta Score obtained 365-Days Post-Procedure(From Index Procedure (Day 0) through study completion assessed up to 365-days post-procedure)