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Completed

NCT Number: NCT02785237

Intra-patient Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT (Optical Coherence Tomography) Follow up

The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic de Barcelona, Barcelona, Spain

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About this study

The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥ 18 years
  • Signature of informed consent
  • Patients with angina and a clinical indication for coronary revascularisation with a drug-eluting stent
  • Presence of at least 2 lesions to be revascularised with similar angiographic characteristics
  • Reference lesion diameter with at most a difference of 0.5 mm
  • Maximum difference in lesion length of 10 mm
  • Lesions able to be treated with only 1 stent

Exclusion criteria

  • Lesions due to restenosis
  • Lesions in saphenous vein grafts
  • STE-ACS ( ST elevation- Acute Coronary Syndrome)
  • Cardiogenic shock
  • Dual antiplatelet therapy contraindication for> 3 months
  • Follow-up catheterisation contraindicated
  • Chronic kidney failure with creatinine > 2 mg/dL
  • Allergy to iodinated contrast agents
  • Serious complication from vascular access in previous catheterisation
  • Ineligible for evaluation via optical coherence tomography
  • Lesion located <5 mm from aorto-ostial junction
  • Severe proximal angulation >90º
  • Bifurcation lesion requiring a strategy with two stents
  • Angiographic characteristics that promote stent malposition
  • Aneurysm or coronary artery ectasia
  • Presence of a thrombus classed as TIMI (Thrombolysis In Myocardial Infarction )2 flow or higher
  • Severe calcification, in particular in cases of calcium spike
  • Severe lesion angulation
  • Inability to do reliable follow-up, in the investigator's opinion

Treatment and study plan

Coroflex® ISAR Drug-eluting stent

Device

Coroflex® ISAR Drug-eluting stent and an Ultimaster® Drug-eluting stent in the second lesion.

Ultimaster® Drug-eluting stent

Device

Ultimaster® Drug-eluting stent and a Coroflex® ISAR Drug-eluting stent in the second lesion.

Primary outcomes

  1. Percentage of early coating on the struts of the Coroflex® ISAR Drug-eluting stent versus Ultimaster® - Drug eluting stent at 3 months OCT after stent implantation.

    Time frame: 3 months

  2. Percentage of covered struts at 3 months OCT after stent implantation.

    Time frame: 3 months

  3. Percentage of stents with ≥3% of uncovered struts at 3 months OCT after stent implantation.

    Time frame: 3 months

  4. Percentage of uncovered struts ≥3% at 3 months OCT after stent implantation.

    Time frame: 3 months

  5. Number of transversal sections with a percentage (rate of uncovered struts/ total number of struts) > 30 % at 3 months OCT after stent implantation.

    Time frame: 3 months

Secondary outcomes

  1. Percentage of covered struts, at 1 month, 2 months and 3 months OCT after stent implantation.

    Time frame: 1 month and 2 months and 3 months

  2. Total Tissue coverage at 1month, 2 months and 3 months OCT after stent implantation.

    Time frame: 1 month and 2 months and 3 months

  3. Mean thickness of struts tissue coverage at 1 month, 2 months and 3 months OCT after stent implantation.

    Time frame: 1 month and 2 months and 3 months

  4. MACE (Major Adverse Cardiac Events) at 30 days, 3 months, 6 months and 12 months.

    Time frame: 30 days and 3 months and 6 months and 12 months

  5. Target lesion revascularization and target vessel revascularization at 30 days, 3 months, 6 months and 12 months OCT after stent implantation .

    Time frame: 30 days and 3 months and 6 months and 12 months

  6. Percentage of stent malapposition at 1 month and 3 months OCT after stent implantation.

    Time frame: 1 month and 2 months and 3 months

  7. Percentage of struts malapposition at 1 month and 3 months OCT after stent implantation.

    Time frame: 1 month and 2 months and 3 months

  8. Percentage of struts malapposition> 260 µm at 1 month and 3 months OCT after stent implantation.

    Time frame: 1 month and 2 months and 3 months

  9. Percentage of stents with any malapposition strut > 260 µm at 1 month and 3 months OCT after stent implantation.

    Time frame: 1 month and 2 months and 3 months

  10. Healing Score at 1 month and 3 months OCT after stent implantation .

    Time frame: 1 month and 2 months and 3 months

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

Intra-patient Randomized Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT Follow up

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 27, 2016
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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