STENT PATENCY AND STENOSIS IN TIPS

NIH GUIDE, Volume 23, Number 29, August 5, 1994



PA NUMBER:  PA-94-090



P.T. 34



Keywords:

  Cardiovascular Diseases 

  Hypertension 



National Institute of Diabetes and Digestive and Kidney Diseases



PURPOSE



The purpose of this Program Announcement (PA) is to encourage research

on the nonsurgical Transjugular Intrahepatic Porto-Systemic Shunt

(TIPS) procedure in the areas of stent patency and stent stenosis.  The

TIPS procedure has recently become available for the treatment of

portal hypertension, variceal bleeding, and ascites.  At present the

long term effectiveness of TIPS is related to shunt patency and stent

stenosis.  Studies related to technological advances that improve long

term patency as well as studies on stent occlusion and fibrosis are

encouraged.



HEALTHY PEOPLE 2000



The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention objectives of "Healthy People 2000" a

PHS-led national activity for setting priority areas.  This PA, Stent

Patency and Stenosis in TIPS, is related to the priority area of

chronic disabling conditions.  Potential applicants may obtain a copy

of "Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or

"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)

through the Superintendent of Documents, Government Printing Office,

Washington, DC 20402-9325 (telephone 202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by for-profit and non-profit

organizations, public and private, such as universities, colleges,

hospitals, laboratories, units of State and local governments, and

eligible agencies of the Federal government.  Foreign institutions are

not eligible for First Independent Research and Transition (FIRST)

(R29) awards.  Applications from minority individuals and women are

encouraged.



MECHANISM OF SUPPORT



The support for this program announcement will be through the NIH

research project grant (R01) award and the FIRST (R29) award.

Applications seeking support of technological improvements of stents

may consider the Small Business Innovation Research (SBIR) program

(R43) or the Small Business Technology Transfer (STTR) program (R41) of

the NIH, in which the NIDDK participates.  For-profit applicants for

the SBIR and STTR programs must qualify as a small business concern in

accordance with the definition given in the latest edition of the

OMNIBUS SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS

INNOVATION RESEARCH (SBIR) GRANT AND COOPERATIVE AGREEMENT

APPLICATIONS, available from:  MTL, Inc., 13687 Baltimore Avenue,

Laurel, MD 20707-5096, telephone (301) 206-9385; FAX (301) 206-9722,

Internet address: a2y@cu.nih.gov.



RESEARCH OBJECTIVES



Transjugular intrahepatic porto-systemic shunt has recently become

available for the treatment of portal hypertension, variceal bleeding

and ascites.  The TIPS procedure is highly effective in reducing portal

pressure and is thus beneficial in the medical management of patients

with acute variceal hemorrhage.  However, TIPS is an invasive procedure

and is associated with several potential complications.  These

complications can be categorized according to those relating to

transhepatic needle puncture, transvenous access to the portal vein,

portal venous cannulation, portosystemic shunting and the stent.  At

present, long term efficacy is related to shunt patency.  For the first

year after undergoing the procedure, delayed stenosis or occlusion of

the shunt has been reported in 33 to 66 percent of the patients.  The

pathological process results from either hyperplasia and collagen

deposition within the stent or the narrowing of the vascular lumen at

the portal venous end of the TIPS stent. New technologies or advances

in existing technologies to develop stent materials should be directed

to improve long term patency.  Further studies to develop research

should be directed at elucidating methods to reduce fibrosis and or

occlusion of the stent.  The latter studies could focus on the role of

anticoagulation agents, anti-collagen or fibrotic agents, or

anti-inflammatory regimens, such as cytokines, in the maintenance of

stent patency.  Thus, applications are requested that would improve the

technology involving stent patency.



INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS



It is the policy of the NIH that women and members of minority groups

and their subpopulations must be included in all NIH supported

biomedical and behavioral research projects involving human subjects,

unless a clear and compelling rationale and justification is provided

that inclusion is inappropriate with respect to the health of the

subjects or the purpose of the research.  This new policy results from

the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43)

and supersedes and strengthens the previous policies (Concerning the

Inclusion of Women in Study Populations, and Concerning the Inclusion

of Minorities in Study Populations), which have been in effect since

1990. The new policy contains some provisions that are substantially

different from the 1990 policies.



All investigators proposing research involving human subjects should

read the "NIH Guidelines For Inclusion of Women and Minorities as

Subjects in Clinical Research," which have been published in the

Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted

in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March

18, 1994.



Investigators also may obtain copies of the policy from the program

staff listed under INQUIRIES.  Program staff may also provide

additional relevant information concerning the policy.



APPLICATION PROCEDURES



Applications are to be submitted on the grant application form PHS 398

(rev. 9/91).  Applications will be accepted at the regular application

deadlines as indicated in the application kit.  The receipt dates for

applications for AIDS- related research are found in the PHS 398

instructions.



Application kits are available at most institutional offices of

sponsored research and may be obtained from the Office of Grants

Information, Division of Research Grants, National Institute of Health,

Westwood Building, Room 449,Bethesda, MD  20992, telephone 301/594-

7248.  The title and number of this program announcement must be typed

in Section 2a on the face page of the application.



The completed original application and five legible copies must be sent

or delivered to:



Division of Research Grants

National Institute of Health

Westwood Building Room 240

Bethesda, MD  20892**



Applicants from institutions that have a General Clinical Research

Center (GCRC) funded by the NIH National Center for Research Resources

may wish to identify the GCRC as a resource for conducting the proposed

research.  If so, a letter of agreement from either the GCRC program

director or a Principal Investigator must be included with the

application.



FIRST Award applications must include at least three sealed letters of

reference attached to the face page of the original application.  FIRST

Award applications submitted without the required number of reference

letters will be considered incomplete and will be returned without

review.



REVIEW CONSIDERATIONS



Applications will be assigned on the basis of established PHS referral

guidelines and will be reviewed for scientific and technical merit by

study sections of the Division of Research Grants, NIH in accordance

with the standard NIH peer review procedures.  Following

scientific-technical review, the applications will receive a

second-level review by an appropriate National Advisory Council.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications.  The following will be considered in making funding

decisions:



o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Program balance among research areas of the announcement



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.



Direct inquiries regarding programmatic issues to:



Thomas F. Kresina, Ph.D.

Division of Digestive Diseases and Nutrition

National Institute of Digestive Diseases and Kidney Diseases

Westwood Building, Room 3A17

45 Center Drive MSC 6600

Bethesda, MD  20892-6600

Telephone:  (301) 594-7578



Direct inquiries regarding fiscal matters to:



Ms. Paulette Badman

Grants Management Branch

National Institute of Digestive Diseases and Kidney Diseases

Westwood Building, Room 639

45 Center Drive MSC 6600

Bethesda, MD  20892-6600

Telephone:  (301) 594-7543



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

No. 93.848.  Awards are made under authorization of the Public Health

Service Act, Title IV, Part A (Public Law 78- 410, as amended by Public

Law 99-158, 42 USC 241 and 285) and administered under PHS grants

policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74.  This

program is not subject to the intergovernmental review requirements of

Executive Order 12372 or Health Systems Agency review.



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