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Percutaneous Transluminal Coronary Angioplasty (PTCA) Registries I, II, and III and the Dynamic Registry

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pittsburgh Identifier:
First received: May 25, 2000
Last updated: January 12, 2016
Last verified: January 2016
To evaluate the long-term efficacy of percutaneous transluminal coronary angioplasty (PTCA) and alternative angioplasty devices in patients with coronary heart disease. There are four registries. The first registry followed 3,079 patients who received PTCA between 1977 and 1982. The second registry followed 1,500 patients from the first registry for a minimum of five years and followed 2,000 newly entered patients who received PTCA in 1985 and 1986 so that the second cohort would also be followed for five years. The third registry, the New Approaches to Coronary Intervention (NACI), followed approximately 4,424 patients between November 1990 and February 1997. The dynamic evaluation study will follow a total of 6,000 procedures.

Cardiovascular Diseases Coronary Disease Heart Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamic Evaluation of Coronary Intervention

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Death and MI [ Time Frame: 1-year and 5-years ]
    Time to death or non-fatal MI was assessed at 1-year in all recruitment waves and at 5-years in only the recruitment waves that had extended follow-up

Secondary Outcome Measures:
  • Repeat PCI and Repeat Revascularization [ Time Frame: 1-year and 5-years ]
    Time to repeat percutaneous coronary intervention and need for any repeat revascularization (repeat PCI + coronary artery bypass graft surgery) by 1-year for all recruitment waves and by 5-years for recruitment waves with extended follow-up

Other Outcome Measures:
  • Stent thrombosis [ Time Frame: within 30 days and beyond 30-days ]
    Acute stent thrombosis occurs within 30-days of stent placement and late stent thrombosis occurs after 30-days within a stent placed during the index PCI

Enrollment: 4290
Study Start Date: August 1980
Study Completion Date: January 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coronary heart disease who have undergone percutaneous transluminal coronary angioplasty (PTCA) and have alternative angioplasty devices

Inclusion Criteria:

  • Coronary heart disease
  • Undergone percutaneous transluminal coronary angioplasty (PTCA)
  • Have alternative angioplasty devices
  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 identifier: NCT00005677

Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Sheryl F Kelsey, PhD University of Pittsburgh
Principal Investigator: Jeffery Popma Medlantic Research Institute
  More Information


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Pittsburgh Identifier: NCT00005677     History of Changes
Other Study ID Numbers: 1023
U01HL033292 ( U.S. NIH Grant/Contract )
Study First Received: May 25, 2000
Last Updated: January 12, 2016

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Vascular Diseases
Arterial Occlusive Diseases processed this record on September 21, 2017