N/A
Completed N=147
Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System
Vascular Closure
Source: ClinicalTrials.gov NCT03756558 ↗
Enrolled (actual)
147
Serious AEs
28.6%
Results posted
Sep 2025
Primary outcomePrimary: Freedom From Major Complications — 83 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Major Complications |
83 | — |
| PRIMARY Mean Time To Hemostasis (TTH) |
0.4 | — |
| SECONDARY Freedom From Minor Complications |
84 | — |
| SECONDARY Number of Participants With Device Related Complications Within 30 Days Post-procedure |
9 | — |
| SECONDARY Incidence of Adverse Events |
62 | — |
| SECONDARY Incidence of Technical Success |
102 | — |
| SECONDARY Incidence of Closure Success |
99 | — |
| SECONDARY Incidence of Treatment Success |
98 | — |
| SECONDARY Incidence of Surgical or Endovascular Intervention Post Closure |
8 | — |
| SECONDARY Incidence of Manual Compression |
31 | — |
| SECONDARY Time-to-Ambulation: |
15.9 | — |
| SECONDARY Incidence of Device Failure |
— | — |
| SECONDARY Incidence of Procedure Related Complications |
9 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is ≥ 18 years old
- 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
- Subject is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
- Subject is willing and able to complete follow-up requirements
- Subject, or authorized representative signs a written Informed Consent form prior participating in the study
Exclusion Criteria
General Exclusion Criteria
- Prior intra-aortic balloon pump at access site
- 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
- Common femoral artery lumen diameter is 1.5 cm in diameter), arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the access site
- 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
- Angiographic evidence of arterial laceration, dissection, or stenosis in the femoral artery that would preclude use of the investigational device
- Target arteriotomy >18 French sheath
Data sourced from ClinicalTrials.gov (NCT03756558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.