OCT vs IVUS vs QCA to Guide Moderate-to-severe Calcified Lesion Stent Implantation

NCT03574636 | Unknown DMC

• 1 other identifier: TARGET 3C
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, multi-center, randomized controlled clinical trial, aims to assess the safety and effectiveness of Optical Coherence Tomography or Intravascular Ultrasound or Quantitative Coronary Analysis to guide Firehawk stent implantation , and compared the treatment of moderate-to-severe calcified lesion in coronary artery.

Conditions

Optical Coherence Tomography; Intravascular Ultrasound; Angiography

Outcome Measures

Primary Outcomes (1)

• in-stent late loss

  the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 13 months after the procedure

  13 months

Secondary Outcomes (2)

• instant Minimum Stent Area (MSA)

  during PCI procedure

• stent neointimal thickness

  3 months

Other Outcomes (4)

• Target Vessel Revascularization (TVR)

  In hospital and at 30 days, 3, 6, 12 ,13 months and 2-5 years after index procedure

• Target Vessel Failure (TVF)

  In hospital and at 30 days, 3, 6, 12 ,13 months and 2-5 years after index procedure

• Target Lesion Revascularization (TLR)

  In hospital and at 30 days, 3, 6, 12 ,13 months and 2-5 years after index procedure

Study Arms (3)

OCT guidance

ACTIVE COMPARATOR

Firehawk stent implantation will be performed with Optical Coherence Tomography guidance. At the end of the procedure, a final DSA imaging run and OCT measurement must be performed. At 13-month follow-up, DSA imaging run must be performed. At 3-month follow-up, OCT imaging run must be performed in the first 66 consecutive patients.

Device: OCT guidance

IVUS guidance

ACTIVE COMPARATOR

Firehawk stent implantation will be performed with Intravascular Ultrasound guidance. At the end of the procedure, a final DSA imaging run and OCT measurement must be performed. At 13-month follow-up, DSA imaging run must be performed. At 3-month follow-up, OCT imaging run must be performed in the first 66 consecutive patients.

Device: IVUS guidance

QCA guidance

ACTIVE COMPARATOR

Firehawk stent implantation will be performed with Intravascular Ultrasound guidance. At the end of the procedure, a final DSA imaging run and OCT measurement must be performed. At 13-month follow-up, DSA imaging run must be performed. At 3-month follow-up, OCT imaging run must be performed in the first 66 consecutive patients.

Device: QCA

Interventions

OCT guidance DEVICE

OCT guide stent implantation

OCT guidance

IVUS guidance DEVICE

IVUS guide stent implantation

IVUS guidance

QCA DEVICE

QCA guide stent implantation

QCA guidance

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be 18 to 80 years age
• Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed;
• Subject is eligible for percutaneous coronary intervention (PCI);
• Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia (including NST-ACS, stable CAD and STEMI（duration over 4 weeks）);
• Subjects are eligible candidates for coronary artery bypass graft surgery (CABG);
• Left ventricular ejection fraction (LVEF) detected by cardiac ultrasound within 30 days ≥ 30%;
• Subject is willing to comply with all protocol-required follow-up evaluation.
• The target lesion must be a new lesion and has moderate-to-severe calcification which located in a visually estimated reference diameter ≥2.5 mm and ≤4.0 mm in native coronary artery;
• Target lesion diameter stenosis ≥70% and ≤99%
• Target lesion length ≤70mm
• Judgment of moderate-to-severe calcification:
• Grade II (moderate) calcification:
• Before angiography with or without contrast agent injected, the opacity and deformation of coronary artery can be basically seen, the contour of coronary artery can be basically seen and the contrast agent can fully cover the opacity of blood vessel
• Grade III (severe) calcification:
• Before angiography with or without contrast agent injected, the opacity and deformation of coronary artery can be basically seen, the contour of coronary artery is clearly visible and the contrast agent can partially cover the opacity of blood vessel

You may not qualify if:

• Subjects recently suffer from STEMI (within 4 week), and ECG changes/clinical symptoms consistent with AMI or accompanied with increased cardiac biomarkers (CK-MB, CK, TNT or TNI) , and if any of the following criteria is meet in the procedure, patients are excluded; CK-MB\> 2ULN, regardless of the value of total CK; total CK\> 2ULN, CK-MB or Tn is abnormal;
• If CK-MB or CK was not detected, but cTN\> 1ULN, and at least one of the following:
• schemic symptoms and ECG changes of new ischemia; Development of pathologic Q waves in the ECG; Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
• Subject with hemodynamic instability or severely decreased activity tolerance (KILLIP classification \>2 or NYHA classification \>2 );
• Severely ejection fraction reduced heart failure ( LVEF \< 30%)
• Subjects were detected ventricular aneurysm greater than 3.0\*2.0cm or intraventricular thrombosis by cardiac ultrasonography in 30 days;
• Subjects had an organ transplant or are waiting for an organ transplant;
• Subjects are receiving chemotherapy or will receive a chemotherapy within 30 days after PCI;
• Subjects are undergoing chronic (over 72 hours) anticoagulant therapy (such as heparin and coumarin) other than acute coronary syndrome;
• Subjects have confirmed or suspected liver disease, including hepatitis lab results;
• Subjects with elevated serum creatinine level \>3.0mg/dL or undergoing dialysis therapy
• Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion;
• Subjects with cerebral vascular accident (CVA) or transient ischemic attack (TIA) in the past 6 months, or with permanent nerve defects;
• Subjects had any PCI (such as balloon angioplasty, stent, cutting balloon,atherectomy) treatment in target vessels (including collateral) within 13 months prior to baseline;
• Within10mm proximal or distal to the target lesion (including branch artery) had received any PCI prior to baseline;

Sponsors & Collaborators

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

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

Study Officials

• Yundai Chen, MD

  The General Hospital of People's Liberation Army(301 hospital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Zheng, MD

CONTACT

(86)(21)38954600-6229; mzheng@microport.com

Yundai Chen, MD

CONTACT

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: June 20, 2018
• First Posted: July 2, 2018
• Study Start: October 18, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2025
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

CN (1)