Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System

Not Applicable

Completed

• Conditions: Vascular Closure
• Interventions: Device: Cross-Seal System

• Registration Number: NCT03756558
• Lead Sponsor: Terumo Medical Corporation

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.

Study Timeline

• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Study Start: 2019-08-09
• Primary Completion: 2021-03-22
• Study Completion: 2021-03-22
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cross-Seal System	Cross-Seal System	The Cross-Seal System will be used in all subjects enrolled in the study

Primary Outcome Measures

Name	Time	Method
Freedom from Major Complications	30 days post procedure	Freedom from major complications of the target limb. Major Complications include: access site vascular injury that requires surgical intervention, access related lower extremity ischemia, access site infection
Mean Time To Hemostasis (TTH)	30 days post procedure	The mean Time To Hemostasis in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device.

Secondary Outcome Measures

Name	Time	Method
Incidence of Device and procedural complications	30 days post procedure	Adverse Events occurring in the study will be evaluated for device and/or procedural relationships to the device by the study investigator and/or Clinical Events Committee. The incidence reported will not include units, but rather be presented for each event as the occurrence rate by percentage (n/N, proportion) as applicable.
Incidence of Adverse Events	60 days post procedure	Incidence of major and minor Adverse Events (AEs)
Incidence of Closure Success	up to 30 days	Incidence of access site closure success: defined as technical success and freedom from major complications
Incidence of Treatment Success	30 days post procedure	Incidence of Treatment Success: defined as technical success and freedom from major complications
Time-to-Ambulation:	up to 30 days	Time-to-Ambulation: defined as elapsed time from final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding.
Incidence of Technical Success	30 days post procedure	Incidence of hemostasis with the investigational device without the need for any access-site-related adjunctive surgical or endovascular intervention (target limb only).
Incidence of Device Failure	30 days post procedure	Incidence of device failure
Incidence of surgical or endovascular intervention post closure	30 days post procedure	Subjects requiring adjunctive surgical or endovascular intervention to achieve hemostasis of the access site (target limb only) including type of adjunctive intervention.
Freedom from minor complications	30 days post procedure	The freedom from minor complications at the target limb access site. Minor Complications include: pseudoaneurysm at the access site, access site hematoma over 10cm, access site wound dehiscence
Incidence of Manual Compression	30 days post procedure	Incidence of subjects requiring adjunctive manual compression following use of the investigational device to achieve hemostasis of the access site (target limb only).

Trial Locations

Locations (20)

University of Rochester; 🇺🇸 Rochester, New York, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Texas Heart Institute and Baylor St. Luke's Medical Center; 🇺🇸 Houston, Texas, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Cardiothoracic and Vascular Surgeons; 🇺🇸 Austin, Texas, United States

St. David's Heart and Vascular dba Austin heart; 🇺🇸 Austin, Texas, United States

Rutgers, The State University of New Jersey; 🇺🇸 Piscataway, New Jersey, United States

University of Iowa Hospital; 🇺🇸 Iowa City, Iowa, United States

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States

The Trustees of Columbia University in the City of New York; 🇺🇸 New York, New York, United States

Lankenau Institute for Medical Research; 🇺🇸 Wynnewood, Pennsylvania, United States

Vascular Institute of the Rockies; 🇺🇸 Denver, Colorado, United States

River City Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Mt Sinai Medical Center; 🇺🇸 New York, New York, United States

North Central Heart; 🇺🇸 Sioux Falls, South Dakota, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

Sentara Medical Group; 🇺🇸 Norfolk, Virginia, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

INTEGRIS Cardiovascular Physicians; 🇺🇸 Oklahoma City, Oklahoma, United States

Holston Valley Medical Center; 🇺🇸 Kingsport, Tennessee, United States