Absorb GT1 Japan PMS

NCT03409731 | Completed Results FDA Device

• 1 other identifier: 16-310
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for evaluating clinical use results.

Conditions

Ischemic Heart Disease; Angina Pectoris; Coronary Artery Disease; Coronary Artery Occlusion; Myocardial Ischemia

Keywords

Drug eluting Bio-resolvable Scaffold (BRS); Bio-resolvable Scaffold (BRS); Real world

Outcome Measures

Primary Outcomes (16)

• Number of Participants With Acute Scaffold Thrombosis (ST)

  Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.

  Day 0

• Number of Participants With Sub Acute Scaffold Thrombosis (ST)

  Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation.

  >1 to 30 days

• Number of Participants With Late Scaffold Thrombosis (ST)

  Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation.

  31 to 90 days

• Number of Participants With Late Scaffold Thrombosis (ST)

  Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation.

  31 to 365 days

• Number of Participants With Very Late Scaffold Thrombosis (ST)

  Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.

  366 to 730 days

• Number of Participants With Overall Scaffold Thrombosis (ST)

  Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation

  0 to 90 days

• Number of Participants With Cumulative Scaffold Thrombosis

  Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation

  0 to 90 days

• Number of Participants With Cumulative Scaffold Thrombosis

  Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation

  0 to 730 days

• Number of Participants With Exclusion of Very Small Vessels

  For Phase 1 patients, Angiograms and IVUS/OCT images taken during procedure will be sent immediately to the core lab. Additional training or revision of registration criteria may occur as required in order to exclude almost all lesions with RVD \< 2.5 mm from registration by the last half of Phase 1.

  During index procedure, "54.8 ± 27.6 min"

• Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging

  IVUS/OCT images taken during procedure will be sent immediately to the core lab, which will analyze the images and give feedback to the site as required. Images of ST, if occurred, will also be sent to the core lab.

  During index procedure, "54.8 ± 27.6 min"

• Number of Participants With Composite of Device Deficiencies

  Device deficiencies: Number of participants with at least one of the following Device deficiencies 1. Lesion/implant failure 2. Delivery difficulty (finally delivered) 3. Re-crossing failure 4. Re-crossing difficulty 5. Post-dilatation balloon 6. Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS) 7. Instruction for Use (IFU) not included 8. Major Strut Malapposition 9. Strut Fracture within 6 months

  During index procedure, "54.8 ± 27.6 min"

• Number of Participants With Late Scaffold Thrombosis (ST)

  Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.

  731 - 1095 days

• Number of Participants With Cumulative Scaffold Thrombosis

  Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation

  0 - 1095 days

• Number of Participants With Very Late Scaffold Thrombosis (ST)

  Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation

  1096 - 1460 days

• Number of Participants With Cumulative Scaffold Thrombosis

  Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation

  0 - 1460 days

• Number of Participants With Cumulative Scaffold Thrombosis

  Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.

  0 - 1825 days

Secondary Outcomes (85)

• Number of All Death (Cardiac, Vascular, Non-Cardiovascular)

  0 to 30 days

• Number of All Death (Cardiac, Vascular, Non-Cardiovascular)

  0 to 90 days

• Number of All Death (Cardiac, Vascular, Non-Cardiovascular)

  0 to 1 year

• Number of All Death (Cardiac, Vascular, Non-Cardiovascular)

  0 to 2 years

• Number of Participants With All Myocardial Infarction (MI)

  0 to 30 days

Study Arms (1)

Absorb GT1 BVS

OTHER

Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.

Device: ABSORB GT1 BVS

Interventions

ABSORB GT1 BVS DEVICE

Patients receiving Absorb GT1 BVS

Absorb GT1 BVS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• General Percutaneous coronary intervention (PCI) population.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (15)

Nagoya Daini Red Cross Hospital

Nagoya, Aichi-ken, 466-8650, Japan

Location

Shin Tokyo Hospital

Matsudo, Chiba, 270-2232, Japan

Location

Shin Koga Hospital

Kurume, Fukuoka, 830-8577, Japan

Location

Hanaoka Seishu Memorial Cardiovascular Clinic

Sapporo, Hokkaido, 062-0003, Japan

Location

Kobe University

Kobe, Hyōgo, 650-0017, Japan

Location

Iwate Medical University

Morioka, Iwate, 020-8505, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, 247-8533, Japan

Location

Kurashiki Central Hospital

Kurashiki, Okayama-ken, 710-8602, Japan

Location

Saitama Sekishinkai Hospital

Sayama, Saitama, 350-1323, Japan

Location

Mitsui Memorial Museum

Chiyoda City, Tokyo, 101-8643, Japan

Location

Toho University Ohashi Medical Center

Meguro City, Tokyo, 153-8515, Japan

Location

Teikyo University

tabashi City, Tokyo, 173-8606, Japan

Location

Saiseikai Kumamoto Hospital

Kumamoto, 861-4193, Japan

Location

Miyazaki Medical Association Hospital

Miyazaki, 880-0834, Japan

Location

Sakurabashi Watanabe Hospital

Osaka, 530-0001, Japan

Location

Related Publications (1)

• Nakamura M, Suzuki N, Fujii K, Furuya J, Kawasaki T, Kimura T, Sakamoto T, Tanabe K, Kusano H, Stockelman KA, Kozuma K. The Absorb GT1 Bioresorbable Vascular Scaffold System - 5-Year Post-Market Surveillance Study in Japan. Circ J. 2024 May 24;88(6):863-872. doi: 10.1253/circj.CJ-23-0877. Epub 2024 Mar 13.

  PMID: 38479861 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia; Angina Pectoris; Coronary Artery Disease; Coronary Occlusion

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Hajime Kusano
• Organization: Abbott medical device

hajime.kusano@abbott.com

+1 408-845-1626

Study Officials

• Masato Nakamura, MD

  Toho University Ohashi Medical Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: January 24, 2018
• Study Start: December 13, 2016
• Primary Completion: February 6, 2023
• Study Completion: February 6, 2023
• Last Updated: August 6, 2024
• Results First Posted: January 3, 2019

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

JP (15)