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Coronary Arterial DiseaseFORWARD IVLNCT07109479

Safety and Effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter Combined With the Intravascular Lithotripsy Therapy Device

A study testing Intravascular Lithotripsy and Rotational Atherectomy in people with Coronary Arterial Disease, run by Spectrumedics Medical Technology(Shanghai)Co.,Ltd at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The FORWARD IVL trial is a Prospective, Multicenter Study conducted to assess the safety and effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter combined with the Intravascular Lithotripsy Therapy Device for the pre-treatment of calcified, stenotic de novo coronary artery lesions . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Arterial Disease
What is being tested?
Intravascular Lithotripsy and Rotational Atherectomy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
1 Oct 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • General Inclusion Criteria:
  • 1) Age ≥18 years, male or female.
  • 2)Primary coronary artery disease (with evidence of asymptomatic myocardial ischemia, stable/unstable angina, or old MI) scheduled for non-emergent PCI.
  • 3)Pre-procedure Left Ventricular Ejection Fraction (LVEF) ≥30%.
  • 4)Voluntarily participate in this study and sign Informed Consent Form (ICF), willing to comply with study procedures and follow-up.
  • Angiographic Inclusion Criteria:
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  • Target lesion is de novo calcified stenotic coronary lesion with no prior intervention.
  • Target lesion reference vessel diameter is 2.5-4.0 mm.
  • Target lesion meets ONE of the following:
  • RCT part: Moderate-to-severe calcification AND stenosis ≥90% and <100% (length ≤60 mm). (Moderate Calcification: Clearly visible high-density shadows during cardiac motion; Severe Calcification: Clearly visible high-density shadows visible without cardiac motion).
  • Single-arm part: Calcified lesion AND Chronic Total Occlusion (CTO) (length ≤20 mm).
  • Guidewire positioned in the true lumen distal to the target lesion and not in the subintimal space prior to device use.

Who cannot join

  • General Exclusion Criteria
  • 1) Planning use of scoring/cutting balloons, Excimer Laser Coronary Atherectomy (ELCA), or Coronary Intravascular Lithotripsy balloons for calcified lesion modification prior to study device use.
  • 2) NYHA Class III or IV.
  • 3) Currently on dialysis or serum creatinine level >2.5 mg/dL (or 221 µmol/L).
  • 4) Severe coagulation disorder (platelet count <100×10⁹/L).
  • 5) Hyperviscosity diseases (e.g., polycythemia vera, platelet count >750×10⁹/L).
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  • 6) Cardiac shock with clinical signs or symptoms.
  • 7) Active systemic infection.
  • 8) Moderate-to-severe anemia (hemoglobin <90 g/L).
  • 9) Acute Myocardial Infarction within 1 month prior to procedure.
  • 10) Stroke or Transient Ischemic Attack (TIA) within 3 months prior to procedure.
  • 11) Active gastrointestinal ulcer or bleeding within 3 months prior to procedure.
  • 12) Expected life expectancy <12 months as assessed by the investigator.
  • 13) Known intolerance to antiplatelet or anticoagulant therapy.
  • 14) Known allergy to study device components or contrast media.
  • 15) Known pregnancy or lactation (female subjects).
  • 16) Participating or planning to participate in another drug or device clinical trial.
  • 17) Other conditions deemed unsuitable for participation by the investigator
  • Angiographic Exclusion Criteria:
  • Unprotected left main coronary artery disease (stenosis >50%).
  • Serious angiographic complication in the target vessel prior to study device use.
  • Presence of thrombus or suspected thrombus in the target vessel.
  • Aneurysm within 10 mm of the target lesion in the target vessel.
  • Presence of other lesions with stenosis >50% within the target vessel.
  • CTO lesion with excessive tortuosity (>45°) or length >20 mm.
  • Stent implanted within 5 mm proximal or distal to the target lesion.
  • Target lesion accessible only via saphenous vein graft (SVG) or arterial graft.
  • Failure of guidewire to successfully cross the target lesion.
  • Planned use of Antegrade Dissection Re-entry (ADR), Retrograde Wiring (RW), or Retrograde Dissection Re-entry (RDR) techniques

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fei Yu contact

15996030368

fei.yu@spectrumedics.com

China1 site

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Prospective, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter Combined With the Intravascular Lithotripsy Therapy Device for Pre-treatment of De Novo Calcified Stenotic Coronary Lesion

The FORWARD IVL trial is a Prospective, Multicenter Study conducted to assess the safety and effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter combined with the Intravascular Lithotripsy Therapy Device for the pre-treatment of calcified, stenotic de novo coronary artery lesions .

Read the detailed description

The approved IVL devices are based on balloon design, and the biggest limitation is the crossability, especially in the severe stenosis lesions.

Coronary Forward IVL Catheter allow the catheter to modify calcium in tight, difficult to cross lesions to increase the compliance of the vessel and allow further crossing of the device or additional treatment.

This trial consists of two parts:

Part 1 (RCT part): this part is a prospective, multicenter, randomized controlled, study in subjects with moderate-to-severe calcification.180 eligible subjects are planned to enroll .

Part 2 (Single-arm part):This part is a single-arm study in subjects with calcified lesions that are Chronic Total Occlusions (CTOs)(with minimum 30 subjects).

Being tested
Intravascular Lithotripsy, Rotational Atherectomy

What participants receive

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

  • Intravascular LithotripsyDevice

    study group will receive the investigational devices (Single-Use Coronary Forward Intravascular Lithotripsy Catheter combined with the Intravascular Lithotripsy Therapy Device) for calcified lesion pre-treatment.

  • Rotational AtherectomyDevice

    control group will receive the control device (Coronary Rotational Atherectomy System)

Study groups in NCT07109479
Study groupRoleWhat they receive
Intravascular LithotripsyExperimentalNot described
Receives: Device: Intravascular Lithotripsy
Coronary Rotational AtherectomyActive comparatorNot described
Receives: Device: Rotational Atherectomy

What is being measured

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

  1. Rate of Device Success

    Measured: immediately after IVL intervention

  2. Freedom from Major Adverse Cardiovascular Events (MACE) within 30 days post-procedure

    Measured: 30-day after the procedure

Secondary outcomes (10)

  1. Rate of Technical Success

    Measured: immediately after the procedure

  2. Rate of Angiographic Success

    Measured: Peri-procedural

  3. Rate of Procedural Success

    Measured: at discharge/up to 7 days after the procedure

  4. Incidence of serious angiographic complications

    Measured: immediately after the procedure

  5. Incidence of MACE

    Measured: during procedure, at discharge (up to 7 days after the procedure) ,180 days after the procedure

  6. Incidence of Target Lesion Failure

    Measured: during procedure, at discharge (up to 7 days after the procedure), 30 days after the procedure, 180 days after the procedure

  7. Incidence of Patient-Oriented Cardiovascular Endpoint

    Measured: during procedure, at discharge (up to 7 days after the procedure), 30 days after the procedure, 180 days after the procedure

  8. Incidence of Device Deficiencies

    Measured: immediately after the prcedure

  9. Excellent rate of device performance evaluation

    Measured: Immediately after the procedure

  10. Incidence of Adverse Events and Serious Adverse Events

    Measured: through study completion, 180 days after the procedure

Timeline

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

  1. First posted7 Aug 2025
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07109479
Sponsor's protocol ID
PC-SWFC-01
Acronym
FORWARD IVL
Status last verified
Jul 2025
First submitted
22 Jul 2025
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Intravascular Lithotripsy and Rotational Atherectomy in people with Coronary Arterial Disease, run by Spectrumedics Medical Technology(Shanghai)Co.,Ltd at 1 site in China.

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 12 inclusion and 29 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: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Fei Yu (15996030368, fei.yu@spectrumedics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Device Success (time frame: immediately after IVL intervention). 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 NCT07109479.

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 7 Aug 2025.

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