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Coronary Microcirculatory and Bioresorbable Vascular Scaffolds

NCT03076476 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-04-22

No results posted yet for this study

Summary

Angina and heart attacks are caused by narrowings in the coronary arteries (blood vessels) supplying the heart. These narrowings can be opened using a balloon and stent (angioplasty). Traditionally, stents are constructed from metal and are permanent. However, newer stents are being constructed from carbohydrate polymers (scaffolds), which allow them to reabsorb over time leaving no permanent implant. New data has suggested that these scaffolds appear to reduce recurrent angina and may alter the blood flow down the artery. However, it is not known whether this is due to the scaffolds themselves or the way the scaffolds are inserted. In this study we hope to measure the blood flow to the heart and assess changes in that flow during stent and scaffold insertion. It is also important to know whether these effects are durable and thus, a cohort of patients will return at 3-months to be restudied. These data are important to help us understand why blood flow is affected by stent/scaffold selection or device implantation technique and whether this results in better long-term outcomes.

Conditions

  • CHD - Coronary Heart Disease
  • Angina, Stable
  • Myocardial Ischemia

Interventions

DEVICE

Bioresorbable Vascular Scaffolds (BVS)

Bioresorbable Vascular Scaffold. Introduced after the interim analysis (phase 2) for comparison with DES-slow.

DEVICE

Drug-Eluting Stent (DES) - slow

Slow device inflation (mandated in the BVS IFU). To be compared with the DES-std group at interim analysis at the end of phase 1 stage. After the interim analysis DES-slow to be compared with BVS.

DEVICE

Drug-Eluting Stent (DES) - standard(std)

Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage.

Sponsors & Collaborators

  • Papworth Hospital NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Melissa Duckworth · Papworth NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2021-03-10
Completion
2021-03-10

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03076476 on ClinicalTrials.gov