xDot Access Management System Pivotal Study

Official title

xDot Access Management System Pivotal Study for Closure of Large Bore Femoral-Arterial & Venous-Access Sites

Overview

The objective of this study is to establish reasonable assurance of safety and effectiveness for the xDot Access Management System (AMS) when used as indicated for femoral-arterial and femoral-venous closure. Additionally, this study will provide preliminary evidence on the impact on health outcomes for patients undergoing interventional catheterization procedures when the xDot AMS is used for vascular closure.

Detailed description

The study is a prospective, multicenter, dual-cohort, single-arm, open-label IDE pivotal trial enrolling patients undergoing catheter-based interventional procedures requiring large bore femoral arterial or femoral venous access, comprising:

* A single-arm Femoral Arterial cohort for evaluation of the xDot AMS for closure of femoral arterial access sites ("Femoral Arterial cohort"), and * A single-arm Femoral Venous cohort for evaluation of the xDot AMS for closure of femoral venous access sites ("Femoral Venous cohort")

The study includes a roll-in cohort consisting of treatment-only subjects, which will be analyzed and presented separately and will not contribute to the pivotal analysis populations.

Interventions

• Device xDot Access Management System (AMS)
  The xDot AMS is designed to deliver the xDot Implant Unit around the access site on the target vessel to close the puncture site.

Primary outcome measures

• Freedom from major complications of the target access site for Femoral Arterial cohort [Time frame: 30 days post-procedure]
• Time to hemostasis (TTH) for Femoral Arterial cohort [Time frame: During procedure]
• Freedom from major complications of the target access site for Femoral Venous cohort [Time frame: 30 days post-procedure]
• Time to hemostasis (TTH) for Femoral Venous cohort [Time frame: During procedure]

Secondary outcome measures (2)

• Time-to-ambulation (TTA) for Femoral Arterial cohort [Time frame: 48 hours post-procedure]
• Time-to-ambulation (TTA) for Femoral Venous cohort [Time frame: 48 hours post-procedure]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years
• Willing and able to provide written informed consent prior to initiation of study procedures
• Willing and able to comply with the protocol-specified procedures and assessments
• Investigator opinion suitable for xDot AMS for femoral closure (arterial or venous, as applicable)
• Minimum vessel diameter of 5.5 mm and vessel depth ≥1.5 cm and ≤5.0 cm, <50% stenosis for the:

• femoral artery, as determined by pre-procedural computed tomography angiography (CTA) and confirmed by ultrasound at the time of procedure (arterial vessel sizing can be assessed by ultrasound at index procedure if pre-procedure CTA is not SOC).
• femoral vein, as determined by ultrasound at the time of procedure.
• Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedure through:

• The common femoral artery using 8F to 22F devices or sheaths (max 26F OD; including, but not limited to TAVR and EVAR)
• The common femoral vein using 8F to 26F devices or sheaths (max 30F OD; including, but not limited to transcatheter mitral/tricuspid valve repair/replacement and LAA occlusion)

Exclusion criteria

• If female, individuals who are pregnant, planning to become pregnant, or lactating
• Immunocompromised or with pre-existing autoimmune disease
• Active systemic infection or a local infection at or near the access site
• Known or suspected COVID-19 infection
• Significant anemia (hemoglobin <10 g/dL, hematocrit <30%)
• Morbidly obese or cachectic (Body mass index \[BMI\] >40 kg/m\^2 or <20 kg/m\^2)
• Severe co-existing co-morbidities which, in the opinion of the investigator, would clinically confound the study primary endpoints
• Known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
• Allergy to any device material, including polypropylene, NiTinol, or Titanium
• Common femoral artery or vein with calcium, as determined by baseline CTA or angiogram, which, in the clinical judgment of the investigator, precludes safe access, or severe peripheral vascular disease as evidenced by severe claudication when ambulating <100 feet, weak or absent pulses in the affected limb, or ankle-brachial index (ABI) <0.5 at rest
• Previous iliofemoral intervention in the region of the access site, including prior atherectomy, stenting, or surgical or grafting procedures
• Use of an intra-aortic balloon pump through the access site within 30 days prior to the baseline evaluation
• Continuous oral anticoagulation therapy that cannot be stopped for the peri-procedural period or international normalized ratio (INR) >1.8 at the time of the procedure
• Unable to be adequately anti-coagulated for the procedure
• Unable to ambulate at baseline (e.g., wheelchair user or confined to bed)
• ST-elevation myocardial infarction (MI) within 30 days prior to procedure or acute coronary syndrome (i.e., unstable angina or MI) ≤30 days before the catheterization procedure
• New York Heart Association (NYHA) class IV heart failure
• Left ventricular ejection fraction <20%
• Unilateral or bilateral lower extremity amputation
• Renal insufficiency (serum creatinine >2.5 mg/dl) or on dialysis therapy
• Existing nerve damage in the ipsilateral leg
• Additional planned endovascular procedure within the next 30 days
• Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period
• Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07719244 · xDOT-CL-5100

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗