Clinical trial NCT03756558: Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System
Official title: Cross-SealTM IDE Trial: Prospective, Multi-Center, Single Arm Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Closure
Lead sponsor: Terumo Medical Corporation
Sponsor class: INDUSTRY
First posted: 2018-11-28
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Performance goal
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety and effectiveness of the Cross-Seal vascular closure device in gaining post procedure hemostasis in subjects undergoing interventional procedures requiring an 8 to 18 french size introducer sheath.

Detailed description: The Cross-Seal device is a VCD intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (8-18F ID) interventional devices. The function of Cross-Seal is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure.

The study is being conducted to demonstrate the safety and effectiveness of Cross-Seal in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.

Eligibility criteria: Inclusion Criteria:

1. Subject is ≥ 18 years old
2. Subject is scheduled for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedures involving access through the femoral artery using 8-18 French introducer sheaths
3. Subject is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
4. Subject is willing and able to complete follow-up requirements
5. Subject, or authorized representative signs a written Informed Consent form prior participating in the study

Exclusion Criteria:

General Exclusion Criteria

1. Prior intra-aortic balloon pump at access site
2. Subjects with severe inflow disease (iliac artery diameter stenosis \> 50%) and/or severe peripheral arterial disease (Rutherford Classification 5 or 6), as confirmed with prior standard of care Computed Tomography Imaging, duplex ultrasound, and/or intra-procedural fluoroscopy
3. Common femoral artery lumen diameter is \< 5 mm
4. In opinion of the investigator, significant scarring of the target access site which would preclude use of the device in accordance with the IFU
5. Prior target artery closure with any closure device \< 90 days, or closure with manual compression ≤ 30 days prior to index procedure
6. Prior vascular surgery, vascular graft, or stent in region of access site
7. Subjects receiving glycoprotein IIb/IIIa inhibitors before, during, or after the catheterization procedure
8. Subjects with significant anemia
9. Subject with known bleeding disorder including thrombocytopenia (platelet count \< 100,000), thrombasthenia, hemophilia or Von Willebrand's disease
10. Subject with renal insufficiency, on dialysis therapy, or with renal transplant
11. Known severe allergy to contrast reagent that cannot be managed with premedication
12. Inability to tolerate aspirin and/or other anticoagulation/antiplatelet treatment
13. Planned anticoagulation therapy post-procedure such that the Activated Clotting Time (ACT) is expected to be elevated above 350 seconds for more than 24 hours after the procedure
14. Connective tissue disease (e.g., Marfan's Syndrome)
15. Thrombolytics (e.g., streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants ≤ 24 hours prior to the procedure
16. Recent (within 8 weeks) cerebrovascular accident or Q-wave myocardial infarction
17. Subjects who are morbidly obese
18. Planned major intervention or surgery, including planned endovascular procedure in the target leg, within 30 days following the interventional procedure
19. Subject unable to ambulate at baseline (i.e., confined to wheelchair or bed)
20. Currently participating in a clinical study of an investigational device or drug that has not completed its primary study endpoint
21. Known allergy to any device component
22. Subject is known or suspected to be pregnant or lactating
23. Evidence of active systemic or local groin infection
24. Subject has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating
25. Subject is mentally incompetent or a prisoner
26. New York Heart Association (NYHA) Class IV heart failure that is uncontrolled and requires treatment in the Intensive Care Unit within 24 hours prior to the index procedure
27. Left Ventricular Ejection Fraction (LVEF) \< 20%
28. Unilateral or bilateral lower extremity amputation
29. Known existing nerve damage in the target leg
30. Subjects who have already participated in this study

    Intra-Procedure Exclusion Criteria
31. Access site above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks
32. Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels
33. Ipsilateral femoral venous sheath during the catheterization procedure
34. Common femoral artery calcium, which is visible with prior Computed Tomography Imaging and/or duplex ultrasound
35. Subject in which there is difficulty inserting the introducer sheath or need for greater than 2 ipsilateral arterial punctures at the start of the catheterization procedure
36. Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
37. Evidence of a pre-existing hematoma (\> 1.5 cm in diameter), arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the access site
38. Marked tortuosity (at the investigator's discretion) of the femoral or external iliac artery in the target leg based on prior Computed Tomography imaging, fluoroscopy, and/or duplex ultrasound
39. Angiographic evidence of arterial laceration, dissection, or stenosis in the femoral artery that would preclude use of the investigational device
40. Target arteriotomy \>18 French sheath

Primary outcomes:
measure: Freedom from Major Complications
timeFrame: 30 days post procedure
measure: Mean Time To Hemostasis (TTH)
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Freedom from minor complications
timeFrame: 30 days post procedure
measure: Incidence of Device and procedural complications
timeFrame: 30 days post procedure
measure: Incidence of Adverse Events
timeFrame: 60 days post procedure
measure: Incidence of Technical Success
timeFrame: 30 days post procedure
measure: Incidence of Closure Success
timeFrame: up to 30 days
measure: Incidence of Treatment Success
timeFrame: 30 days post procedure
measure: Incidence of surgical or endovascular intervention post closure
timeFrame: 30 days post procedure
measure: Incidence of Manual Compression
timeFrame: 30 days post procedure
measure: Time-to-Ambulation:
timeFrame: up to 30 days
measure: Incidence of Device Failure
timeFrame: 30 days post procedure
Other outcomes:
Locations:
city: Denver
country: United States
facility: Vascular Institute of the Rockies
state: Colorado
city: Jacksonville
country: United States
facility: River City Clinical Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospital
state: Iowa
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Piscataway
country: United States
facility: Rutgers, The State University of New Jersey
state: New Jersey
city: New York
country: United States
facility: Mt Sinai Medical Center
state: New York
city: New York
country: United States
facility: The Trustees of Columbia University in the City of New York
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: INTEGRIS Cardiovascular Physicians
state: Oklahoma
city: Wynnewood
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Sioux Falls
country: United States
facility: North Central Heart
state: South Dakota
city: Kingsport
country: United States
facility: Holston Valley Medical Center
state: Tennessee
city: Austin
country: United States
facility: Cardiothoracic and Vascular Surgeons
state: Texas
city: Austin
country: United States
facility: St. David's Heart and Vascular dba Austin heart
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute and Baylor St. Luke's Medical Center
state: Texas
city: Norfolk
country: United States
facility: Sentara Medical Group
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Cardiothoracic and Vascular Surgeons - Austin
name: Mazin Foteh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahan School of Medicine at Mt Sinai
name: Prakash Krishnan
role: PRINCIPAL_INVESTIGATOR
References: