Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03756558|
Recruitment Status : Active, not recruiting
First Posted : November 28, 2018
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Vascular Closure||Device: Cross-Seal System||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Performance goal|
|Masking:||None (Open Label)|
|Official Title:||Cross-SealTM IDE Trial: Prospective, Multi-Center, Single Arm Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System|
|Actual Study Start Date :||August 9, 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Cross-Seal System
The Cross-Seal System will be used in all subjects enrolled in the study
Device: Cross-Seal System
Use of the Cross-Seal system to close the femoral arteriotomy
- Freedom from Major Complications [ Time Frame: 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) [ Time Frame: 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.
- Freedom from minor complications [ Time Frame: 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 Device and procedural complications [ Time Frame: 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 [ Time Frame: 60 days post procedure ]Incidence of major and minor Adverse Events (AEs)
- Incidence of Technical Success [ Time Frame: 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 Closure Success [ Time Frame: up to 30 days ]Incidence of access site closure success: defined as technical success and freedom from major complications
- Incidence of Treatment Success [ Time Frame: 30 days post procedure ]Incidence of Treatment Success: defined as technical success and freedom from major complications
- Incidence of surgical or endovascular intervention post closure [ Time Frame: 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.
- Incidence of Manual Compression [ Time Frame: 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).
- Time-to-Ambulation: [ Time Frame: 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 Device Failure [ Time Frame: 30 days post procedure ]Incidence of device failure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03756558
|Principal Investigator:||Mazin Foteh, MD||Cardiothoracic and Vascular Surgeons - Austin|
|Principal Investigator:||Prakash Krishnan||Icahan School of Medicine at Mt Sinai|