Trial record 5 of 21 for:    abbott and absorb

To Study the Safety and Clinical Outcomes of the Absorb Bioresorbable Vascular Scaffold (BVS) System in Patients With de Novo Lesions in Previously Untreated Vessels (ABSORB UK)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Abbott Vascular
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01977534
First received: October 18, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.


Condition Intervention
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Device: Absorb BVS

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb BVS

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Acute Success: Device success (lesion based analysis) [ Time Frame: From the start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    Achievement of a final in-scaffold residual diameter stenosis of < 50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device is considered to have failed if it did not meet the requirements of the definition for clinical device success.

  • Acute Success: Procedural success (patient based analysis) [ Time Frame: From the start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    Achievement of a final in-scaffold diameter stenosis of < 50% by online QCA or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure.

  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)

  • MI [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
    Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)

  • Target Lesion Revascularization (TLR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    all TLR

  • TLR [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
    all TLR

  • TLR [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    clinically indicated (ID-TLR)

  • TLR [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
    ID-TLR

  • Target Vessel Revascularization (TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    all TVR

  • TVR [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
    all TVR

  • TVR [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    clinically indicated (ID-TVR)

  • TVR [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
    ID-TVR

  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint) [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)) [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
  • Scaffold/Stent Thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    acute, sub-acute, late and very late

  • Scaffold/Stent Thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Definite, Probable

  • Scaffold/Stent Thrombosis [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
    acute, sub-acute, late and very late

  • Scaffold/Stent Thrombosis [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
    Definite, Probable


Other Outcome Measures:
  • Acute Procedural Analyses (all patients) [ Time Frame: During the implantation procedure ] [ Designated as safety issue: Yes ]
    • Access site (femoral, brachial, radial)
    • Lesion preparation (Lesion 1, 2, 3, etc.)

      • Balloon pre-dilatation (yes - Max balloon size/Max balloon pressure, Cutting balloon yes/no, Other yes/no)
      • Techniques used to adequately prepare the lesion (de-calcification techniques (Rotablator yes/no, Other yes/no))
    • Treatment parameters

      • CASS numbers
      • No. of scaffolds per analyzable lesion (Lesion 1, 2, 3, etc.)
      • Scaffold length (Lesion 1, Lesion 2, Lesion 3, etc.)
      • Lesion length (Lesion 1, Lesion 2, Lesion 3, etc.)
      • Bailout / bailout device (if bailout required)
    • Post-treatment of lesion?

      • Balloon post-dilatation (no, yes - Max balloon diameter/Max balloon pressures/balloon length)
      • Jailed side-branch (no, yes). If yes, treatment of jailed sidebranch? (no, yes)


Estimated Enrollment: 1000
Study Start Date: January 2014
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Absorb BVS
Subjects receiving Absorb BVS
Device: Absorb BVS
The Absorb BVS System is a bioresorbable poly(L-lactide) (PLLA) scaffold with a drug and bioresorbable polymer coating [formulation of everolimus in a bioresorbable poly(D,L-lactide) (PDLLA) coating].

Detailed Description:

ABSORB UK registry is a prospective, single arm, post-market registry designed to:

  • Provide ongoing post-market surveillance for documentation of safety and clinical outcomes of the Absorb Everolimus Eluting BVS System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use).
  • Collect additional information (e.g. acute success) to evaluate handling and implantation of Absorb BVS by physicians under a wide range of commercial use conditions and following routine clinical practice.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be selected from the general interventional cardiology population

Criteria

Inclusion Criteria:

The inclusion criteria must follow the most recent IFU which may include but are not limited to the following:

  • Patient must be at least 18 years of age at the time of signing the Informed Consent Form
  • Patient is to be treated for de novo lesions located in previously untreated vessels.
  • Patient must agree to undergo all required follow-up visits and data collection.

Exclusion Criteria:

The exclusion criteria must follow the most recent IFU which may include but are not limited to the following:

  • Inability to obtain a signed informed consent from potential patient.
  • Patient belongs to a vulnerable population (per investigator's judgment, this also includes people with a direct link (hierarchical or financial benefit) to the registry Doctor or the registry Sponsor).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01977534

Contacts
Contact: Kathleen Peeters 32-2-4169399 kathleen.peeters@av.abbott.com

Locations
United Kingdom
Basildon Hospital Recruiting
Basildon, United Kingdom
Contact: Alamgir Kabir         
Bristol Heart Institute Recruiting
Bristol, United Kingdom
Contact: Andreas Baumbach         
Papworth Hospital Recruiting
Cambridge, United Kingdom
Contact: Nick West         
The Freeman Hospital Recruiting
Newcastle, United Kingdom
Contact: Azfar Zaman         
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Andreas Baumbach Bristol Heart institute
Study Director: Peter Staehr, MD Abbott Vascular
Study Director: Susan Veldhof Clinical Science
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01977534     History of Changes
Other Study ID Numbers: 13-304
Study First Received: October 18, 2013
Last Updated: June 5, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Abbott Vascular:
Bioabsorbable
Coronary Stent
Everolimus
drug eluting stents
stents
angioplasty
coronary artery disease
total coronary occlusion
coronary artery restenosis
stent thrombosis
vascular disease
myocardial ischemia
coronary artery stenosis
CAD
CAOD

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Coronary Restenosis
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Stenosis
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014