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Vascular Closure DeviceNCT07858903

Initial Safety and Preliminary Efficacy of the Novelrad Vascular Closure System (NVCS)

A study testing Novelrad Vascular Closure System (NVCS) in people with Vascular Closure Device and Femoral Arteriotomy Closure, run by Novelrad Ltd. at 3 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the initial safety and preliminary efficacy of the Novelrad Vascular Closure System (NVCS), a suture-mediated vascular closure system, in achieving post-procedure hemostasis in subjects undergoing interventional catheterization procedures through the common femoral artery using large-bore… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Novelrad Vascular Closure System (NVCS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
3 sitesIsrael
Study dates
30 Nov 2025to 18 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 8-22 French introducer sheaths such as TAVI/TAVR/EVAR/TEVAR etc.
  • Subject has suitable sized vessel / calcification as evaluated on pre-procedural CT angiography by the investigator and by the study' screening committee
  • Subject is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
  • Understand and sign the study specific written informed consent form
  • Able and willing to fulfill the follow-up requirements

Who cannot join

  • Baseline Exclusions:
  • Known to be pregnant or lactating.
  • Immunocompromised or with pre-existing autoimmune disease.
  • Systemic infection or a local infection at or near the access site.
  • Significant anemia (Hgb < 9 g/dL hematocrit <30%).
  • Morbidly obese or cachectic (BMI >40 kg/m2 or <20kg/m2).
Show all 53Show fewer
  • Known bleeding disorders including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, von Willebrand disease, or hypercoagulability.
  • Known allergy to any device component.
  • Femoral artery puncture in target groin within the prior 14 days, recent femoral artery puncture in target groin that has not healed appropriately, and/or prior vascular closure device placement in target common femoral artery that the investigator determines may interfere with the NVCS.
  • Common femoral artery with calcium, as determined by baseline CTA, precluding safe access in the opinion of the investigator or severe peripheral vascular disease as evidenced by severe claudication when ambulating < 30 meter, weak or absent pulses in the affected limb.
  • Previous intervention in region of access site, including but not limited to prior atherectomy, stenting, surgical or grafting procedures in the access area.
  • Prior target artery closure with any closure device < 180 days, or closure with manual compression ≤ 90 days prior to index procedure.
  • Subjects who have undergone use of an intra-aortic balloon pump through the arterial access site.
  • Undergoing therapeutic thrombolysis.
  • Subjects in whom oral anticoagulation therapy cannot be stopped for the peri-procedural period or subjects with INR >1.8 at the time of the procedure.
  • Subject unable to be adequately anti-coagulated for the procedure.
  • Subjects who are not mobile and are confined to a wheelchair or bed.
  • ST-elevation MI within 45 days prior to procedure or acute coronary syndrome (i.e., unstable angina or myocardial infarction) ≤14 days before the catheterization procedure
  • 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, or after renal transplant.
  • Existing nerve damage in the NVCS treated leg.
  • Further planned endovascular procedure within the next 30 days.
  • Subjects currently participating in another clinical study of an unapproved investigational device or drug that has not concluded the follow-up period.
  • Subject cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life-threatening disease.
  • Common femoral artery <6mm or >50% diameter femoral stenosis by baseline CTA and/or severe peripheral arterial disease or Rutherford Classification 5 or 6.
  • 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.
  • Known severe allergy to contrast reagent that cannot be managed with premedication.
  • Connective tissue disease (e.g., Marfan's Syndrome).
  • Thrombolytics (e.g., streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants ≤ 24 hours prior to the procedure.
  • Subject is mentally incompetent or a prisoner.
  • Planned antegrade puncture during the index procedure.
  • Stenosis >50% diameter of access site's ipsilateral iliac artery that the investigator determines may interfere with the NVCS.
  • Subject unable to ambulate at baseline (i.e., confined to wheelchair or bed).
  • Intra-Procedure Exclusions:
  • On baseline Duplex US the Common femoral artery <6mm or >50% stenosis of the femoral artery.
  • Puncture site took place in the profunda femoris artery, superficial femoral artery, or at the bifurcation of these arteries or if less than one third of the access needle is above the skin line indicating the subject is morbidly obese.
  • Common femoral artery suspected to have experienced a back wall puncture or underwent > one (1) arterial puncture during the catheterization procedure.
  • Difficult dilation from initial femoral artery access (e.g., damaging or kinking dilators) while step dilating up to the large-bore device.
  • Actual puncture site located above the most inferior border of the epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks.
  • Marked tortuosity of femoral or iliac artery that to the opinion of the user prohibiting the use of the device.
  • Systolic blood pressure >180 mmHg or diastolic blood pressure >110 mm Hg, unless systolic or diastolic pressure can be lowered by pharmacological agents prior to closure.
  • Planned antegrade puncture during the index procedure.
  • Possible bacterial contamination of the procedure's sheath or surrounding tissues during the procedure.
  • Intra-procedural complication(s) at the femoral access site before procedural sheath removal and before sliding the NVCS knot down, including: 1. Bleeding or swelling around the sheath that may indicate hematoma formation and/or pseudoaneurysm formation; and 2. Peri-procedural duplex us/angiographic evidence of thrombus formation or significant injury in the aorta or iliac vessels associated with procedural large bore sheath placement and/or sub-optimal anticoagulation.
  • Presence of ipsilateral femoral venous sheath during the interventional procedure.
  • Systolic blood pressure <90 mm Hg just prior to planned vascular closure without the ability to increase it.
  • 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.
  • Index procedure planned sheath or interventional device >22Fr during the procedure.
  • Evidence of a pre-existing hematoma (> 1.5 cm in diameter), arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the access site before insertion of the NVCS.
  • Duplex US (or by angiography if applicable) evidence of arterial laceration, dissection, or stenosis in the femoral artery that would preclude use of the device.
  • Stenosis >50% diameter of access site's ipsilateral iliac artery that the investigator determines may interfere with the NVCS.

Trial locations and contacts

3 sites in 1 country.

Israel3 sites

  • Hadassah Medical Center

    Jerusalem

  • Shaare Zedek Medical Center

    Jerusalem

  • Sourasky Tel-Aviv Medical Center

    Tel Aviv

Other trials in Israel

About this study

Official title: A First in Human (FIH) Clinical Study to Evaluate the Initial Safety and Preliminary Efficacy of the Suture-Mediated Novelrad Vascular Closure System

This study evaluates the initial safety and preliminary efficacy of the Novelrad Vascular Closure System (NVCS), a suture-mediated vascular closure system, in achieving post-procedure hemostasis in subjects undergoing interventional catheterization procedures through the common femoral artery using large-bore procedural sheaths.

Read the detailed description

The Novelrad Vascular Closure System (NVCS) is an investigational suture-mediated vascular closure device intended for use following percutaneous interventional catheterization procedures performed through the common femoral artery using large-bore procedural sheaths. The NVCS is designed to facilitate percutaneous closure of the arteriotomy using a continuous suture technique.

The study is being conducted to evaluate the initial safety and preliminary efficacy of the NVCS in subjects undergoing percutaneous interventional catheterization procedures using large-bore procedural sheaths.

Being tested
Novelrad Vascular Closure System (NVCS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Novelrad Vascular Closure System (NVCS)Device

    NVCS will be used to close the common femoral artery access site while reducing time-to-hemostasis in subjects who have undergone diagnostic or interventional catheterization procedures using 8-22 French (F) Sheaths.

Study groups in NCT07858903
Study groupRoleWhat they receive
Novelrad Vascular Closure System (NVCS)ExperimentalThe Novelrad Vascular Closure System (NVCS), will be used in subjects who are undergoing diagnostic or interventional catheterization procedures
Receives: Device: Novelrad Vascular Closure System (NVCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: Freedom from major complications of the target limb within 30 days following the procedure

    Assessment of the incidence of protocol defined major complications of the target limb access site through 30 days post procedure as specified in the protocol.

    Measured: Within 30 days post-procedure

  2. Efficacy: Mean Time to Hemostasis

    The Time to Hemostasis is defined as the elapsed time between withdrawal of index procedure sheath from common femoral artery and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma).

    Measured: Periprocedural

Secondary outcomes (8)

  1. Safety: Frequency of minor complications at the target limb.

    Assessment of the incidence of minor complications of the target limb access site as specified in the protocol.

    Measured: Within 30 days post procedure

  2. Efficacy: Technical Success

    Achievement of hemostasis with the NVCS without the need for any access-site-related adjunctive surgical or endovascular intervention (target limb only).

    Measured: Periprocedural

  3. Efficacy: Treatment/Procedure Success

    Subjects with technical success and free from major complications through 30 days follow-up.

    Measured: Within 30 days post procedure

  4. Efficacy: Mean Time for NVCS Procedure

    The elapsed time from initial skin break (first needle insertion) to time when the suture is released from the NVCD plus the elapsed time from performing the knot at the end of the index procedure and until hemostasis is achieved.

    Measured: Periprocedural

  5. Efficacy: Mean Time to Ambulation

    The elapsed time between last procedural sheath removal and when ambulation is achieved (subject is standing and walking at least 6-meters without bleeding).

    Measured: Within 24 hours after procedural sheath removal

  6. Time-to-discharge eligibility

    The time following the removal of the NVCS and when the patient is eligible for discharge based solely on (1) completion TTA, (2) freedom from orthostatic hypotension [defined as stable blood pressure and heart rate after ambulating], (3) ability to void and, (4) a stable access site without bleeding or expansion of a prior hematoma.

    Measured: Within 48 hours after the procedure

  7. Efficacy: Percent of subjects with surgical or endovascular intervention post closure

    Subjects require adjunctive surgical or endovascular intervention to achieve hemostasis of the NVCS access site.

    Measured: Periprocedural

  8. Efficacy: Percent of subjects with NVCS Failure

    When the device is used in accordance with the IFU, but does not perform as described in the IFU, and/or negatively impacts treatment of the study subject.

    Measured: Periprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2026
  2. Study start30 Nov 2025
  3. Primary completion18 Aug 2026
  4. Study completion18 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07858903
Sponsor's protocol ID
NVCS-CLN-001
Status last verified
Sep 2026
First submitted
17 Sep 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Novelrad Vascular Closure System (NVCS) in people with Vascular Closure Device and Femoral Arteriotomy Closure, run by Novelrad Ltd. at 3 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Freedom from major complications of the target limb within 30 days following the procedure (time frame: Within 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07858903.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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