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Coronary Artery DiseaseLARGE-ONENCT05961787

A Trial of DCB vs DES in the Treatment of de Novo Large Diameter Coronary Atherosclerotic Stenosis(LARGE ONE)

A study testing SeQuent® Please drug coating balloon(DCB)，Firehawk family drug eluting stent(DES) in people with Coronary Artery Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

For the treatment of primary large-diameter coronary atherosclerosis through percutaneous coronary intervention (PCI), the use of a drug balloon (DCB) is not inferior to the placement of a drug-eluting stent (Firehawk™ family). Large-diameter vessels were defined as vessels with a diameter of ≥3.00 mm and ≤ 4.0mm Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
SeQuent® Please drug coating balloon(DCB)，Firehawk family drug eluting stent(DES)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteChina
Study dates
30 Dec 2022to Jan 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • CI1. Age of subject 18-75 years old;
  • CI2. The subject (or legal guardian) understands and provides written informed consent to the test requirements and treatment procedures prior to performing any specific tests or procedures in the study;
  • CI3. The subject is suitable for percutaneous coronary intervention (PCI);
  • CI4. The subject had symptomatic coronary artery disease with objective evidence or asymptomatic ischemia;
  • CI5. Subject is willing to submit to all subsequent evaluations required by the test protocol
  • Angiogragh Inclusion
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  • AI1. At Maximum 2 target lesions with stenosis ≥50%, located in no more than 2 vessels with a visual reference vessel diameter (RVD) of ≥3.00 mm and ≤4.00 mm;
  • AI2. The length of the target lesion must be≤35 mm (visually) and can be covered by one study stent or drug balloon;
  • AI3. The first target lesion must be successfully predilated/pretreated without:
  • Vascular tears affecting hemodynamics (TIMI blood grade ≤2);
  • Coronary dissection classified as D, E and F(ARC);
  • Residual stenosis > 30% after lesion preparation;
  • Note: If Type C dissection occurs at lesion predilation/preparation, clinical investigators will determine whether the target lesion can be included based on the comprehensive situation of blood flow and patients risks . Type C dissection will be excluded from the OCT subgroup considering the risk of dissection extension for OCT operation.
  • AI4. The anatomical conditions of the coronary artery were appropriate, and the study instrument could be transported to the appropriate location of the target lesion.

Who cannot join

  • CE1. Subjects with clinical symptoms and/or ECG findings consistent with the diagnosis of acute ST-segment elevation myocardial infarction (STEMI) within 7 days;
  • CE2. Subject is known to be allergic to contrast agents (which cannot be fully pretreated) and/or concomitant medications required by the stent system or protocol (e.g., cobalt-chrome, platinum-chrome, stainless steel, rapamycin, paclitaxel and similar configuration compounds, drug coating carrier components, all P2Y12 receptor inhibitors, aspirin, etc.);
  • CE3. Planned surgical treatment within 6 months after baseline surgery;
  • CE4. Severe heart failure (NYHA Grade IV) or left ventricular ejection fraction <30% (ultrasound or left ventricular contrast);
  • CE5. Previous renal impairment: serum creatinine >2.0mg/dL; Or on dialysis;
  • CE6. Previous bleeding events (BARC III or V);
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  • CE7. Subject is receiving or indication of long-term anticoagulant therapy ;
  • CE8. Subject has any of the following conditions (baseline assessment) :
  • Other serious medical conditions that reduce subjects' life expectancy to less than 13 months (e.g., cancer, congestive heart failure);
  • Subject has a current substance abuse problem (e.g., alcohol, cocaine, heroin, etc.);
  • Subject plans to undergo surgical/intervention procedures that may result in non-compliance with protocol or confusing data interpretation;
  • CE9. Subject has a history of bleeding tendency, coagulation disorders or refusal of blood transfusion;
  • CE10. The subject is participating in a clinical trial of another investigational drug or device that does not meet its primary endpoint;
  • CE11. Subjects are scheduled to participate in another investigational drug or device clinical trial within 13 months of baseline procedure;
  • CE12. Subjects who intend to be pregnant within 13 months of baseline procedure (fertile and sexually active women should consent to use a reliable contraceptive method from screening to 13 months after baseline surgery);
  • CE13. Subjects are pregnant or breastfeeding (fertile women with pregnancy possibility should undergo a pregnancy test within 7 days prior to baseline surgery).
  • Angiogragh Exclusion
  • AE1. Plan to treat 3 or more target lesions;
  • AE2. Plan to treat more than 2 major epicardial vessels;
  • AE3. A single lesion to be treated cannot be covered by a single stent or a single drug balloon;
  • AE4. The subject had two target lesions in the same target vessel, and the distance between the two target lesions was ≤15mm (visual observation);
  • AE5. Target lesions were located in the left main trunk;
  • AE6. Target lesions were located within 3mm of the initial segment of the left anterior descending artery (LAD) or left circumflex artery (LCX).
  • AE7. Target lesions were located in a saphenous vein, artery or artificial bypass graft;
  • AE8. Target lesions need to be treated through a saphenous vein, artery or artificial bypass graft ;
  • AE9. Target lesion blood flow grade of TIMI 0/1 before guide wire passes through ;
  • AE10. Treatment of target lesions involves multi-stent strategy in complex lesions (e.g., bifurcated lesions require more than one stent);
  • AE11. Target lesions involve previously in-stent restenosis lesions or overlap with previously implanted stents;
  • AE12. Subject has unprotected left main coronary artery disease (>50% diameter stenosis);
  • AE13. Subjects have received PCI for any type of target lesion (e.g., balloon dilation, stent placement, balloon dissection, etc.) within 12 months before baseline;
  • AE14. Presence of thrombus or possible thrombus in the target lesion (visual);
  • AE15. The target lesions were moderate to severe calcification lesions.

Trial locations and contacts

1 site in 1 country.

Lijun Gan, doctoral contact

18505370616

13792336453@163.com

China1 site, 1 recruiting

  • Jining Medical University Affiliated Hospital

    Jining, Shandong, 272000

    Lijun Gan, doctoral, 18505370616, 13792336453@163.com

    Recruiting

Other trials in China

About this study

Official title: LARGE-ONE: A Prospective, Multicenter, Randomized Controlled Trial of the Use of Drug-coating Balloons(DCB) or Drug-eluting Stents(DES) in the Treatment of Large Diameter Coronary Atherosclerotic Lesions

For the treatment of primary large-diameter coronary atherosclerosis through percutaneous coronary intervention (PCI), the use of a drug balloon (DCB) is not inferior to the placement of a drug-eluting stent (Firehawk™ family).

  • Large-diameter vessels were defined as vessels with a diameter of ≥3.00 mm and ≤ 4.0mm
Being tested
SeQuent® Please drug coating balloon(DCB)，Firehawk family drug eluting stent(DES)
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • SeQuent® Please drug coating balloon(DCB)，Firehawk family drug eluting stent(DES)Device

    Investigation on DCB vs DES on Symptomatic or silent ischemic coronary artery disease with indications for PCI

    • Lesions ≤35 mm in length (visual), diameter 3-4 mm.
    • A maximum of 2 target lesions on 2 major epicardial coronary target vessels can be treated during baseline procedure. (e.g., one target lesion on one target vessel, or two target lesions on the same target vessel but separated ≥ 15 mm; Or 1 target lesion on each of the target vessels)
Study groups in NCT05961787
Study groupRoleWhat they receive
DCB ARMExperimentalpatients with large primary coronary artery lesions (3.0mm≤ vessel diameter ≤4.0mm, lesion length ≤35mm).
Receives: Device: SeQuent® Please drug coating balloon(DCB)，Firehawk family drug eluting stent(DES)
DES ARMActive comparatorpatients with large primary coronary artery lesions (3.0mm≤ vessel diameter ≤4.0mm, lesion length ≤35mm).
Receives: Device: SeQuent® Please drug coating balloon(DCB)，Firehawk family drug eluting stent(DES)

What is being measured

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

  1. Value of Luminal loss at 13month post procedure

    defined as the difference between the minimum lumen diameter in the lesion segment immediately after use of the study instrument and the minimum lumen diameter at 13 months angiographic follow up .

    Measured: 13 months

Secondary outcomes (5)

  1. Rate of Target Lesion Failure(TLF)

    defined as the composite of cardiac death, target vessel-related myocardial infarction (MI)*, or ischemia-driven target lesion revascularization (TLR)

    Measured: 30 days, 6 months, 1and 2 years

  2. Rate of Major Adverse Cardiac Events(MACE )

    The composite of cardiac death, any MI or ischemia-driven TLR, and stent thrombosis myocardial infarction (MI)*, or ischemia-driven target lesion revascularization (TLR)

    Measured: 30 days, 6 months, 1and 2 years

  3. Value of Neointimal Volume:

    the total volume bounded by the stent and the lumen within the segment of interest. It can be calculated using the formula: [= Stent Volume - Lumen Volume]

    Measured: 3 months post procedure

  4. Value of Stent Volume

    Based on Simpson's rule, the stent volume is calculated as the total volume bounded by the stent within the segment of interest. In the absence of neointimal hyperplasia, malapposition, and tissue protrusion, the stent volume corresponds to the lumen volume.

    Measured: 3 months post procedure

  5. Value of Lumen Volume

    Based on Simpson's rule, the total volume bounded by the lumen within the segment of interest.

    Measured: 3 months post procedure

Timeline

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

  1. First posted27 Jul 2023
  2. Study start30 Dec 2022
  3. Primary completionJan 2025 (estimated)
  4. Study completionJan 2026 (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
None (open label)
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05961787
Sponsor's protocol ID
D-IC-ISR-026
Acronym
LARGE-ONE
Status last verified
Jul 2023
First submitted
6 Dec 2022
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing SeQuent® Please drug coating balloon(DCB)，Firehawk family drug eluting stent(DES) in people with Coronary Artery Disease, run by Shanghai MicroPort Medical (Group) 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 14 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. 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?

Results are not available in the source record.

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

Contact Lijun Gan, doctoral (18505370616, 13792336453@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Value of Luminal loss at 13month post procedure (time frame: 13 months). 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 NCT05961787.

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 27 Jul 2023.

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