CompletedNot Applicable

Absorb IV Randomized Controlled Trial

United States2,604 participantsStarted 2014-07

Plain-language summary

ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States. ABSORB IV is a continuation of ABSORB III (NCT01751906) trial which are maintained under one protocol because both trial designs are related. The data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS. The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the safety and effectiveness as well as the potential short and long-term benefits of Abbott Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System (once commercially available), as compared to the commercially approved, control stent XIENCE.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject must be at least 18 years of age.
✓. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
✓. Subject must have evidence of myocardial ischemia (e.g., silent ischemia, stable or unstable angina, non-ST-segment elevation MI (NSTEMI), OR recent ST-segment elevation MI (STEMI). Patients with stable coronary syndromes can be enrolled any time after symptom onset if eligibility criteria are otherwise met. Patients with acute coronary syndrome can be enrolled under the following conditions:
✓. Unstable angina or NSTEMI within 2 weeks of the index procedure.
✓. STEMI \> 72 hours ≤ 2 weeks prior to the index procedure.
✓. Subjects must be suitable for PCI. Subjects with stable angina or silent ischemia and \< 70% diameter stenosis must have objective signs of ischemia as determined by one of the following: abnormal stress echocardiogram, nuclear scan, electrocardiogram (ECG), positron emission tomography (PET), magnetic resonance imaging (MRI), and/or fractional flow reserve (FFR).
✓. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
✓. Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard.

What they're measuring

Number of Participants With Target Lesion Failure (TLF)

Timeframe: 30 days

Trial details

NCT IDNCT02173379

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-06

Results submitted2018-04-20

View on ClinicalTrials.gov More Coronary Artery Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject must be at least 18 years of age.
✓. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
✓. Subject must have evidence of myocardial ischemia (e.g., silent ischemia, stable or unstable angina, non-ST-segment elevation MI (NSTEMI), OR recent ST-segment elevation MI (STEMI). Patients with stable coronary syndromes can be enrolled any time after symptom onset if eligibility criteria are otherwise met. Patients with acute coronary syndrome can be enrolled under the following conditions:
✓. Unstable angina or NSTEMI within 2 weeks of the index procedure.
✓. STEMI \> 72 hours ≤ 2 weeks prior to the index procedure.
✓. Subjects must be suitable for PCI. Subjects with stable angina or silent ischemia and \< 70% diameter stenosis must have objective signs of ischemia as determined by one of the following: abnormal stress echocardiogram, nuclear scan, electrocardiogram (ECG), positron emission tomography (PET), magnetic resonance imaging (MRI), and/or fractional flow reserve (FFR).
✓. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
✓. Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard.

Absorb IV Randomized Controlled Trial

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Absorb IV Randomized Controlled Trial

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria