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

NCT05961787 | Unknown DMC

• 1 other identifier: D-IC-ISR-026
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (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 .

  13 months

Secondary Outcomes (5)

• Rate of Target Lesion Failure(TLF)

  30 days, 6 months, 1and 2 years

• Rate of Major Adverse Cardiac Events(MACE )

  30 days, 6 months, 1and 2 years

• Value of Neointimal Volume:

  3 months post procedure

• Value of Stent Volume

  3 months post procedure

• Value of Lumen Volume

  3 months post procedure

Study Arms (2)

DCB ARM

EXPERIMENTAL

patients with large primary coronary artery lesions (3.0mm≤ vessel diameter ≤4.0mm, lesion length ≤35mm).

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

DES ARM

ACTIVE COMPARATOR

patients with large primary coronary artery lesions (3.0mm≤ vessel diameter ≤4.0mm, lesion length ≤35mm).

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

Interventions

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)

DCB ARM; DES ARM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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);
• 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);

Sponsors & Collaborators

• Shanghai MicroPort Medical (Group) Co., Ltd.: lead

Study Sites (1)

Jining Medical University Affiliated Hospital

Jining, Shandong, 272000, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ming Zheng, Doctoral

  Shanghai MicroPort Medical (Group) Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Lijun Gan, doctoral

CONTACT

18505370616; 13792336453@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: July 27, 2023
• Study Start: December 30, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

CN (1)